510(k) · Cleared
ClearedEchoPAC Software Only / EchoPAC Plug-in (v211)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Medical Systems Ultrasound and Primary Care Diagnostics · QIH Automated Radiological Image Processing Software
Cleared on Sep 16, 2026 as substantially equivalent to K251342 (GE Medical Systems Ultrasound and Primary Care Diagnostics, 2025) and 1 other predicate after a 124-day review. Its family tree reaches back 27 generations to 1995.
- Decided
- Sep 16, 2026
- Review
- 124 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 27 generations to K935595 (1995). 278 ancestors in all, the oldest K850478 (1985). No later device cites it as a predicate yet.
- Root · 27 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 23 generations between
- 3 generations backK200852 EchoPAC Software Only, EchoPAC Plug-InGE Medical Systems Ultrasound and Primary Care Diagnostics · 2020
- 2 generations backK220940 EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics · 2022
- 1 generation backK251342 EchoPAC Software Only / EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics · 2025
- This deviceK261623 EchoPAC Software Only / EchoPAC Plug-in (v211)GE Medical Systems Ultrasound and Primary Care Diagnostics · 2026
Show all 27 generations
- Root · 27 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 26 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 25 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 24 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 23 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 22 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 21 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 20 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 19 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 18 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 17 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 16 generations backK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- 15 generations backK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
- 14 generations backK110943 Logiq E9GE Healthcare · 2011 · Recalled
- 13 generations backK113690 GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · Recalled
- 12 generations backK120741 Voluson S6, Voluson S8GE Healthcare · 2012
- 11 generations backK131267 Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10GE Healthcare · 2013
- 10 generations backK132913 Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10GE Healthcare · 2013
- 9 generations backK142472 Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound SystemsGE Healthcare · 2015
- 8 generations backK152567 Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound SystemGE Healthcare · 2015
- 7 generations backK160184 Voluson S6, Voluson S8, Voluson S10GE Healthcare · 2016 · Recalled
- 6 generations backK161706 Vivid iqGe Medical Systems Ultrasound and Primary Care Diagnostics L · 2016
- 5 generations backK170878 Vivid S60N, Vivid S70NGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC · 2017 · Recalled
- 4 generations backK182450 Vivid S60N, Vivid S70NGE Medical Systems Ultrasound and Primary Care Diagnostics · 2018 · Recalled
- 3 generations backK200852 EchoPAC Software Only, EchoPAC Plug-InGE Medical Systems Ultrasound and Primary Care Diagnostics · 2020
- 2 generations backK220940 EchoPAC Software Only, EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics · 2022
- 1 generation backK251342 EchoPAC Software Only / EchoPAC Plug-inGE Medical Systems Ultrasound and Primary Care Diagnostics · 2025
- This deviceK261623 EchoPAC Software Only / EchoPAC Plug-in (v211)GE Medical Systems Ultrasound and Primary Care Diagnostics · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −27 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −26 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −25 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −24 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −23 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −22 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −21 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −20 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −19 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −18 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −17 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −16 | K083095 | Sonixtouch Ultrasound System | Ultrasonix Medical Corporation | 2008 | — |
| −15 | K092271 | GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 | GE Healthcare | 2009 | 1 |
| −14 | K110943 | Logiq E9 | GE Healthcare | 2011 | 2 |
| −13 | K113690 | GE Logiq I, Logiq E and Vivid E | GE Healthcare | 2011 | 1 |
| −12 | K120741 | Voluson S6, Voluson S8 | GE Healthcare | 2012 | — |
| −11 | K131267 | Voluson E6/E8/E8EXPERT/E8EXPERT Limited Edition/E10 | GE Healthcare | 2013 | — |
| −10 | K132913 | Voluson E6 / E8 / E8EXPERT / E8EXPERT Limited Edition / E10 | GE Healthcare | 2013 | — |
| −9 | K142472 | Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound Systems | GE Healthcare | 2015 | — |
| −8 | K152567 | Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound System | GE Healthcare | 2015 | — |
| −7 | K160184 | Voluson S6, Voluson S8, Voluson S10 | GE Healthcare | 2016 | 1 |
| −6 | K161706 | Vivid iq | Ge Medical Systems Ultrasound and Primary Care Diagnostics L | 2016 | — |
| −5 | K170878 | Vivid S60N, Vivid S70N | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | 2017 | 2 |
| −4 | K182450 | Vivid S60N, Vivid S70N | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2018 | 2 |
| −3 | K200852 | EchoPAC Software Only, EchoPAC Plug-In | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2020 | — |
| −2 | K220940 | EchoPAC Software Only, EchoPAC Plug-in | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2022 | — |
| −1 | K251342 | EchoPAC Software Only / EchoPAC Plug-in | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2025 | — |
| 0 (this device) | K261623 | EchoPAC Software Only / EchoPAC Plug-in (v211) | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 6 | 0 |
| 1995 | 9 | 0 |
| 1996 | 6 | 0 |
| 1997 | 10 | 0 |
| 1998 | 5 | 0 |
| 1999 | 13 | 0 |
| 2000 | 9 | 0 |
| 2001 | 9 | 0 |
| 2002 | 14 | 0 |
| 2003 | 16 | 0 |
| 2004 | 19 | 0 |
| 2005 | 12 | 0 |
| 2006 | 15 | 0 |
| 2007 | 12 | 0 |
| 2008 | 9 | 0 |
| 2009 | 6 | 0 |
| 2010 | 10 | 0 |
| 2011 | 10 | 0 |
| 2012 | 13 | 0 |
| 2013 | 7 | 0 |
| 2014 | 9 | 0 |
| 2015 | 7 | 0 |
| 2016 | 3 | 0 |
| 2017 | 6 | 0 |
| 2018 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
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 QIH? 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 QIH device
- #1 K213998 cvi42 Auto Imaging Software Applicationscore 23.5 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K251342 | EchoPAC Software Only / EchoPAC Plug-inSummary page 6…hCare 510(k) Premarket Notification Submission Primary Predicate EchoPAC Software Only / EchoPAC Plug-in (K251342) Device(s) Vivid E95 (K220882) Predicate Classification / Class II Product Codes QIH… | 2025 |
| * | K220882 | Vivid E80, Vivid E90, Vivid E95Summary page 6…510(k) Premarket Notification Submission Primary Predicate EchoPAC Software Only / EchoPAC Plug-in (K251342) Device(s) Vivid E95 (K220882) Predicate Classification / Class II Product Codes QIH (primary), LLZ, IYN, IYO, ITX (secondary)… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
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 31 years and passes through 8 companies; a new generation was cleared every 11 months on median.
- 73 of the 278 ancestors have a recall of any class.
How does its category compare?
All QIH devicesQIH Automated Radiological Image Processing Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · QIH
94in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QIH
150in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QIH
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QIH
4in 2025
MAUDE reports naming product code QIH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 11 | 145 | 0 | 0 |
| 2021 | 19 | 125 | 0 | 0 |
| 2022 | 25 | 134 | 0 | 0 |
| 2023 | 45 | 151 | 0 | 0 |
| 2024 | 64 | 141 | 0 | 2 |
| 2025 | 94 | 150 | 0 | 4 |
| 2026 | 78 | 130 | 1 | — |
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 (20), M, Color M modes, Color, Power, Pulsed and CW Doppler modes, Coded Pulse…
Read the full statement (125 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 (20), M, Color M modes, Color, Power, Pulsed and CW Doppler modes, Coded Pulse, Harmonic, 30, and Real time (RT) 30 Mode (40).
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); lntraoperative (vascular); Intra-Cardiac; Thoracic/Pleural and lntra-Luminal.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K261623 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261623: EchoPAC Software Only / EchoPAC Plug-in (v211).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261623
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026