510(k) Report

510(k) · Cleared

Cleared

EchoPAC Software Only, EchoPAC Plug-In

K200852510(k) TraditionalCleared Sep 18, 2020171-day reviewClass II21 CFR 892.2050

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

GE Medical Systems Ultrasound and Primary Care Diagnostics · LLZ System, Image Processing, Radiological

Cleared on Sep 18, 2020 as substantially equivalent to K170847 (GE Medical Systems Ultrasound and Primary Care Diagnostics, 2017) and 3 other predicates after a 171-day review. Its family tree reaches back 24 generations to 1995. 3 later devices descend from it.

Decided
Sep 18, 2020
Review
171 days
Class
Class II
Product code
LLZ
Recalls
None
Predicates
4

Its longest line of descent runs back 24 generations to K935595 (1995). 264 ancestors in all, the oldest K850478 (1985). 3 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2020: 1 other ancestor2018: 1 other ancestor2017: 3 other ancestors2016: 2 other ancestors2015: 6 other ancestors2008: 9 other ancestors2014: 9 other ancestors2013: 7 other ancestors2012: 13 other ancestors2011: 10 other ancestors2007: 12 other ancestors2010: 10 other ancestors2009: 6 other ancestors2006: 15 other ancestors2005: 12 other ancestors2004: 19 other ancestors2003: 16 other ancestors2001: 9 other ancestors2002: 14 other ancestors2000: 9 other ancestors1999: 13 other ancestors1995: 9 other ancestors1998: 5 other ancestors1997: 10 other ancestors1996: 6 other ancestors1994: 6 other ancestors1992: 1 other ancestor1990: 1 other ancestor1986: 1 other ancestor1985: 1 other ancestor1987: 1 other ancestor1993: 1 other ancestor1989: 2 other ancestors2022: 1 descendant cleared2025: 1 descendant cleared2026: 1 descendant clearedK935595 · Acuson Model 3001 · Acuson Corp. · 1995K973767 · Harmonic Imaging with Contrast · Acuson Corp. · 1997K022567 · Sequoia Signature II Diagnostic Ultrasound System · Acuson Corp. · 2002K032114 · Sequoia 8.0 Diagnostic Ultrasound System · Siemens Medical Solutions USA, Inc. · 2003×3: 3 generations cleared close together, K041319 (2004), K042770 (2004), K050240 (2005) K052894 · Sonoline G60 S Ultrasound System · Siemens Medical Solutions USA, Inc. · 2005 · recalled×2: 2 generations cleared close together, K063138 (2006), K063803 (2007) K072786 · Acuson S2000 Ultrasound System · Siemens Medical Solutions USA, Inc. · 2007K083095 · Sonixtouch Ultrasound System · Ultrasonix Medical Corporation · 2008K092271 · GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 · GE Healthcare · 2009 · recalledK110943 · Logiq E9 · GE Healthcare · 2011 · recalled×2: 2 generations cleared close together, K113690 (2011), K120741 (2012) ×2: 2 generations cleared close together, K131267 (2013), K132913 (2013) K142472 · Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound Systems · GE Healthcare · 2015×2: 2 generations cleared close together, K152567 (2015), K160184 (2016) K161706 · Vivid iq · Ge Medical Systems Ultrasound and Primary Care Diagnostics L · 2016K170878 · Vivid S60N, Vivid S70N · GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2017 · recalledK182450 · Vivid S60N, Vivid S70N · GE Medical Systems Ultrasound and Primary Care Diagnostics · 2018 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 5 other ancestors3 generations back: 10 other ancestors4 generations back: 28 other ancestors5 generations back: 24 other ancestors6 generations back: 29 other ancestors7 generations back: 37 other ancestors8 generations back: 37 other ancestors9 generations back: 22 other ancestors10 generations back: 14 other ancestors11 generations back: 10 other ancestors12 generations back: 9 other ancestors13 generations back: 7 other ancestors14 generations back: 5 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 1 descendant K182450 · Vivid S60N, Vivid S70N · GE Medical Systems Ultrasound and Primary Care Diagnostics · 2018 · recalledK170878 · Vivid S60N, Vivid S70N · GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2017 · recalledK161706 · Vivid iq · Ge Medical Systems Ultrasound and Primary Care Diagnostics L · 2016K160184 · Voluson S6, Voluson S8, Voluson S10 · GE Healthcare · 2016 · recalledK152567 · Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound System · GE Healthcare · 2015K142472 · Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound Systems · GE Healthcare · 2015K132913 · Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10 · GE Healthcare · 2013K131267 · Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10 · GE Healthcare · 2013K120741 · Voluson S6, Voluson S8 · GE Healthcare · 2012K113690 · GE Logiq I, Logiq E and Vivid E · GE Healthcare · 2011 · recalledK110943 · Logiq E9 · GE Healthcare · 2011 · recalledK092271 · GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 · GE Healthcare · 2009 · recalledK083095 · Sonixtouch Ultrasound System · Ultrasonix Medical Corporation · 2008K072786 · Acuson S2000 Ultrasound System · Siemens Medical Solutions USA, Inc. · 2007K063803 · Acuson Antares Diagnostic Ultrasound System · Siemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · recalledK063138 · Modification to Acuson Antares Ultrasound System · Siemens Medical Solutions USA, Inc. · 2006K052894 · Sonoline G60 S Ultrasound System · Siemens Medical Solutions USA, Inc. · 2005 · recalledK050240 · Modification to Acuson CV70 Cardiovascular System · Siemens Medical Solutions USA, Inc. · 2005 · recalledK042770 · Modification to Acuson CV70 Cardiovascular System · Siemens Medical Solutions USA, Inc. · 2004 · recalledK041319 · Sequoia Diagnostic Ultrasound System · Siemens Medical Solutions USA, Inc. · 2004K032114 · Sequoia 8.0 Diagnostic Ultrasound System · Siemens Medical Solutions USA, Inc. · 2003K022567 · Sequoia Signature II Diagnostic Ultrasound System · Acuson Corp. · 2002K973767 · Harmonic Imaging with Contrast · Acuson Corp. · 1997K935595 · Acuson Model 3001 · Acuson Corp. · 1995−20−15−10−50
  1. Root · 24 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
  2. 20 generations between
  3. 3 generations backK161706 Vivid iqGe Medical Systems Ultrasound and Primary Care Diagnostics L · 2016
  4. 2 generations backK170878 Vivid S60N, Vivid S70NGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2017 · Recalled
  5. 1 generation backK182450 Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics · 2018 · Recalled
  6. This deviceK200852 EchoPAC Software Only, EchoPAC Plug-InGE Medical Systems Ultrasound and Primary Care Diagnostics · 2020
  7. Descendant · cites it directly · 2 of its ownK220940 EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics · 2022
  8. Descendant · 2 generations on · 1 of its ownK251342 EchoPAC Software Only / EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics · 2025
  9. Descendant · 3 generations on · 0 of its ownK261623 EchoPAC Software Only / EchoPAC Plug-in (v211)GE Medical Systems Ultrasound and Primary Care Diagnostics · 2026
Show all 24 generations
  1. Root · 24 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
  2. 23 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
  3. 22 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
  4. 21 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
  5. 20 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
  6. 19 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
  7. 18 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
  8. 17 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
  9. 16 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
  10. 15 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
  11. 14 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
  12. 13 generations backK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
  13. 12 generations backK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
  14. 11 generations backK110943 Logiq E9GE Healthcare · 2011 · Recalled
  15. 10 generations backK113690 GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · Recalled
  16. 9 generations backK120741 Voluson S6, Voluson S8GE Healthcare · 2012
  17. 8 generations backK131267 Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10GE Healthcare · 2013
  18. 7 generations backK132913 Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10GE Healthcare · 2013
  19. 6 generations backK142472 Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound SystemsGE Healthcare · 2015
  20. 5 generations backK152567 Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound SystemGE Healthcare · 2015
  21. 4 generations backK160184 Voluson S6, Voluson S8, Voluson S10GE Healthcare · 2016 · Recalled
  22. 3 generations backK161706 Vivid iqGe Medical Systems Ultrasound and Primary Care Diagnostics L · 2016
  23. 2 generations backK170878 Vivid S60N, Vivid S70NGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2017 · Recalled
  24. 1 generation backK182450 Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics · 2018 · Recalled
  25. This deviceK200852 EchoPAC Software Only, EchoPAC Plug-InGE Medical Systems Ultrasound and Primary Care Diagnostics · 2020

Most influential descendants

Showing 3 of 3 · See all
  • K220940EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics · 2022 · cites it directly2descendants
  • K251342EchoPAC Software Only / EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics · 2025 · 2 generations on1descendant
  • K261623EchoPAC Software Only / EchoPAC Plug-in (v211)GE Medical Systems Ultrasound and Primary Care Diagnostics · 2026 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−24K935595Acuson Model 3001Acuson Corp.1995—
−23K973767Harmonic Imaging with ContrastAcuson Corp.1997—
−22K022567Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp.2002—
−21K032114Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2003—
−20K041319Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc.2004—
−19K042770Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc.20041
−18K050240Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc.20051
−17K052894Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc.20051
−16K063138Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc.2006—
−15K063803Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI20079
−14K072786Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc.2007—
−13K083095Sonixtouch Ultrasound SystemUltrasonix Medical Corporation2008—
−12K092271GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4GE Healthcare20091
−11K110943Logiq E9GE Healthcare20112
−10K113690GE Logiq I, Logiq E and Vivid EGE Healthcare20111
−9K120741Voluson S6, Voluson S8GE Healthcare2012—
−8K131267Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10GE Healthcare2013—
−7K132913Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10GE Healthcare2013—
−6K142472Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound SystemsGE Healthcare2015—
−5K152567Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound SystemGE Healthcare2015—
−4K160184Voluson S6, Voluson S8, Voluson S10GE Healthcare20161
−3K161706Vivid iqGe Medical Systems Ultrasound and Primary Care Diagnostics L2016—
−2K170878Vivid S60N, Vivid S70NGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20172
−1K182450Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics20182
0 (this device)K200852EchoPAC Software Only, EchoPAC Plug-InGE Medical Systems Ultrasound and Primary Care Diagnostics2020—
+1K220940EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics2022—
+2K251342EchoPAC Software Only / EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics2025—
+3K261623EchoPAC Software Only / EchoPAC Plug-in (v211)GE Medical Systems Ultrasound and Primary Care Diagnostics2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198510
198610
198710
198920
199010
199210
199310
199460
199590
199660
1997100
199850
1999130
200090
200190
2002140
2003160
2004190
2005120
2006150
2007120
200890
200960
2010100
2011100
2012130
201370
201490
201560
201620
201730
201810
202010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202210
202510
202610
FIG. 1 — Lineage of K200852, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LLZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new LLZ device

  1. #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (4)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K170847EchoPAC Software Only, EchoPAC Plug-in
Summary page 4
…for ultrasound image review, analysis and reporting Class Il Picture archiving and communications system, 21 CFR 892.2050, LLZ EchoPAC Software Only / EchoPAC Plug-in (K170847) Vivid S70N (K182450) Vivid E95 (K181685) Vivid E95 (K200743) Main - 19 ) Device Description: Intended Use/ I…
GE Medical Systems Ultrasound and Primary Care Diagnostics2017—
*K182450Vivid S60N, Vivid S70N
Summary page 4
…eview, analysis and reporting Class Il Picture archiving and communications system, 21 CFR 892.2050, LLZ EchoPAC Software Only / EchoPAC Plug-in (K170847) Vivid S70N (K182450) Vivid E95 (K181685) Vivid E95 (K200743) Main - 19 ) Device Description: Intended Use/ Indication for Use: Te…
GE Medical Systems Ultrasound and Primary Care Diagnostics20182
*K181685Vivid E80, Vivid E90, Vivid E95
Summary page 4
…reporting Class Il Picture archiving and communications system, 21 CFR 892.2050, LLZ EchoPAC Software Only / EchoPAC Plug-in (K170847) Vivid S70N (K182450) Vivid E95 (K181685) Vivid E95 (K200743) Main - 19 ) Device Description: Intended Use/ Indication for Use: Technology: Determina…
GE Medical Systems Ultrasound and Primary Care Diagnostics2018—
*K200743Vivid E80/ Vivid E90/ Vivid E95
Cleared while this submission was under review
Summary page 4
…Picture archiving and communications system, 21 CFR 892.2050, LLZ EchoPAC Software Only / EchoPAC Plug-in (K170847) Vivid S70N (K182450) Vivid E95 (K181685) Vivid E95 (K200743) Main - 19 ) Device Description: Intended Use/ Indication for Use: Technology: Determination of GE Healthca…
Ge Medical Systems Ultrasound And2020—

What descends from it? (3)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K220940EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics20222

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 25 years and passes through 8 companies; a new generation was cleared every 11 months on median.
  • 72 of the 264 ancestors have a recall of any class.
  • Of its descendants, K220940 (GE Medical Systems Ultrasound and Primary Care Diagnostics, 2022) has gone furthest, with 2 descendants of its own.

How does its category compare?

All LLZ devices

LLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.

FDA decisions per year · LLZ

58in 2025

2007: 762008: 942009: 702010: 512011: 1062012: 822013: 952014: 782015: 642016: 822017: 782018: 1042019: 742020: 812021: 832022: 652023: 872024: 622025: 582026 (partial year): 45
2007high 106 (2011) · low 51 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LLZ

173in 2025

2007: 36 days median2008: 52 days median2009: 62 days median2010: 98 days median2011: 79 days median2012: 87 days median2013: 84 days median2014: 89 days median2015: 90 days median2016: 90 days median2017: 107 days median2018: 105 days median2019: 107 days median2020: 115 days median2021: 116 days median2022: 137 days median2023: 157 days median2024: 131 days median2025: 173 days median2026 (partial year): 110 days median
2007high 173 (2025) · low 36 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LLZ

11in 2025

2007: 202008: 322009: 212010: 172011: 302012: 122013: 642014: 62015: 162016: 122017: 52018: 72019: 22020: 62021: 32022: 42023: 82024: 62025: 112026 (partial year): 14
2007high 64 (2013) · low 2 (2019)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LLZ

116in 2025

2007: 1522008: 1542009: 1452010: 1452011: 4542012: 2662013: 1,1302014: 15,6312015: 2112016: 2902017: 1042018: 722019: 882020: 822021: 702022: 282023: 262024: 422025: 116
2007high 15,631 (2014) · low 26 (2023)2025

MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007763620152
2008945232154
2009706221145
2010519817145
20111067930454
2012828712266
20139584641,130
20147889615,631
2015649016211
2016829012290
2017781075104
2018104105772
201974107288
202081115682
202183116370
202265137428
202387157826
202462131642
20255817311116
20264511014—

What is it indicated for?

EchoPAC Software Only / EchoPAC Plug-in is intended for diagnostic review and analysis of ultrasound images, patient record management and reporting, for use by, or on the order of a licensed physician. EchoPAC Software Only / EchoPAC Plug-in allows post-processing of raw data images from GE ultrasound scanners and DICOM ultrasound images. Ultrasound images are acquired via B (2D), M, Color M modes, Color, Power, Pulsed and CW Doppler modes, Coded Pulse…

Read the full statement (124 words)

EchoPAC Software Only / EchoPAC Plug-in is intended for diagnostic review and analysis of ultrasound images, patient record management and reporting, for use by, or on the order of a licensed physician. EchoPAC Software Only / EchoPAC Plug-in allows post-processing of raw data images from GE ultrasound scanners and DICOM ultrasound images.

Ultrasound images are acquired via B (2D), M, Color M modes, Color, Power, Pulsed and CW Doppler modes, Coded Pulse, Harmonic, 3D, and Real time (RT) 3D Mode (4D).

Clinical applications include: Fetal/Obstetrics; Abdominal (including renal and GYN), Urology (including prostate), Pediatric; Small organs (breast, testes, thyroid), Neonatal and Adult Cephalic, Cardiac (adult and pediatric), Peripheral Vascular, Transesophageal (TEE), Musculo-skeletal Conventional, Musculo-skeletal Superficial, Transrectal (TR), Transvaginal (TV), Intraoperative (vascular), Intra-cardiac, and Intra-luminal.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from GE Medical Systems Ultrasound and…

68 FDA decisions under this applicant name. See the company

  • K261623EchoPAC Software Only / EchoPAC Plug-in (v211)GE Medical Systems Ultrasound and Primary Care Diagnostics · 2026
  • K261313Vivid Explorer/Vivid Advanced/Vivid FocusGE Medical Systems Ultrasound and Primary Care Diagnostics · 2026
  • K261835LOGIQ FocusGE Medical Systems Ultrasound and Primary Care Diagnostics · 2026
  • K260398LOGIQ eGE Medical Systems Ultrasound and Primary Care Diagnostics · 2026
  • K260673LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro…GE Medical Systems Ultrasound and Primary Care Diagnostics · 2026

Recent decisions in LLZ

The LLZ category page

  • K261788Eden PACSHigia., Inc. d/b/a Eden · 2026
  • K261531PV-iCurve ProPerception Vision Medical Technology Co., Ltd. · 2026
  • K263048Syngo Carbon Space (VA4)Siemens Healthineers AG · 2026
  • K261874Syneris PACS v.1.0.1.0Syneris · 2026
  • K262442HipStudio AnalysisReplasia BV · 2026

https://510kreport.com/device/K200852 · printed Nov 6, 2026

Cite this page

510(k) Report. “K200852: EchoPAC Software Only, EchoPAC Plug-In.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200852

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026