510(k) · Cleared
ClearedLOGIQ Focus
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 · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Jul 30, 2026 as substantially equivalent to K253366 (GE Medical Systems Ultrasound and Primary Care Diagnostics, 2026) after a 58-day review. Its family tree reaches back 24 generations to 1995.
- Decided
- Jul 30, 2026
- Review
- 58 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 24 generations to K935595 (1995). 156 ancestors in all, the oldest K863700 (1987). No later device cites it as a predicate yet.
- Root · 24 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 20 generations between
- 3 generations backK211524 LOGIQ E10s, LOGIQ FortisGE Healthcare · 2021
- 2 generations backK231989 LOGIQ E10s, LOGIQ FortisGe Medical Systems Ultrasound and Primary Care Diagnostic, · 2023
- 1 generation backK253366 LOGIQ FortisGE Medical Systems Ultrasound and Primary Care Diagnostics · 2026
- This deviceK261835 LOGIQ FocusGE Medical Systems Ultrasound and Primary Care Diagnostics · 2026
Show all 24 generations
- Root · 24 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 23 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 22 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 21 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 20 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 19 generations backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- 18 generations backK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 17 generations backK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
- 16 generations backK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- 15 generations backK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- 14 generations backK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- 13 generations backK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
- 12 generations backK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
- 11 generations backK110943 Logiq E9GE Healthcare · 2011 · Recalled
- 10 generations backK113690 GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · Recalled
- 9 generations backK123564 Logiq E9 Diagnostic Ultrasound SystemGE Healthcare · 2012 · Recalled
- 8 generations backK131514 GE Vivid E9 Diagnostic Ultrasound Imaging SystemGe Vingmed Ultrasound AS · 2013 · Recalled
- 7 generations backK152309 LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics · 2015 · Recalled
- 6 generations backK163077 LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics · 2016
- 5 generations backK173555 Logiq E10GE Healthcare · 2017 · Recalled
- 4 generations backK200119 LOGIQ E10sGE Medical Systems Ultrasound and Primary Care Diagnostics · 2020
- 3 generations backK211524 LOGIQ E10s, LOGIQ FortisGE Healthcare · 2021
- 2 generations backK231989 LOGIQ E10s, LOGIQ FortisGe Medical Systems Ultrasound and Primary Care Diagnostic, · 2023
- 1 generation backK253366 LOGIQ FortisGE Medical Systems Ultrasound and Primary Care Diagnostics · 2026
- This deviceK261835 LOGIQ FocusGE 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 |
|---|---|---|---|---|---|
| −24 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −23 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −22 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −21 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −20 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −19 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| −18 | K050240 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −17 | K052894 | Sonoline G60 S Ultrasound System | Siemens Medical Solutions USA, Inc. | 2005 | 1 |
| −16 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| −15 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| −14 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| −13 | K083095 | Sonixtouch Ultrasound System | Ultrasonix Medical Corporation | 2008 | — |
| −12 | K092271 | GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 | GE Healthcare | 2009 | 1 |
| −11 | K110943 | Logiq E9 | GE Healthcare | 2011 | 2 |
| −10 | K113690 | GE Logiq I, Logiq E and Vivid E | GE Healthcare | 2011 | 1 |
| −9 | K123564 | Logiq E9 Diagnostic Ultrasound System | GE Healthcare | 2012 | 1 |
| −8 | K131514 | GE Vivid E9 Diagnostic Ultrasound Imaging System | Ge Vingmed Ultrasound AS | 2013 | 2 |
| −7 | K152309 | LOGIQ E9, LOGIQ E9 XDClear 2.0 | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2015 | 1 |
| −6 | K163077 | LOGIQ E9, LOGIQ E9 XDClear 2.0 | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2016 | — |
| −5 | K173555 | Logiq E10 | GE Healthcare | 2017 | 2 |
| −4 | K200119 | LOGIQ E10s | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2020 | — |
| −3 | K211524 | LOGIQ E10s, LOGIQ Fortis | GE Healthcare | 2021 | — |
| −2 | K231989 | LOGIQ E10s, LOGIQ Fortis | Ge Medical Systems Ultrasound and Primary Care Diagnostic, | 2023 | — |
| −1 | K253366 | LOGIQ Fortis | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2026 | — |
| 0 (this device) | K261835 | LOGIQ Focus | GE Medical Systems Ultrasound and Primary Care Diagnostics | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 5 | 0 |
| 1996 | 1 | 0 |
| 1997 | 6 | 0 |
| 1998 | 2 | 0 |
| 1999 | 7 | 0 |
| 2000 | 7 | 0 |
| 2001 | 7 | 0 |
| 2002 | 11 | 0 |
| 2003 | 12 | 0 |
| 2004 | 14 | 0 |
| 2005 | 10 | 0 |
| 2006 | 8 | 0 |
| 2007 | 5 | 0 |
| 2008 | 5 | 0 |
| 2009 | 5 | 0 |
| 2010 | 7 | 0 |
| 2011 | 3 | 0 |
| 2012 | 7 | 0 |
| 2013 | 2 | 0 |
| 2014 | 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 IYN? 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 IYN device
- #1 K240850 EPIQ Series Diagnostic Ultrasound Systems…score 32.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K253366 | LOGIQ FortisSummary page 5….1570, 90-ITX Medical Image Management and Processing System, 21 CFR 892.2050, 90- QIH Primary Predicate Device: K253366 LOGIQ Fortis Reference Device(s): K242005 Versana Premier, Versana Premier Lotus, LOGIQ F K21… | 2026 |
| † | K242005 | Versana Premier; Versana Premier Lotus; LOGIQ F | 2024 |
| † | K214039 | Logiq P10, Logiq P9, Logiq P8 | 2022 |
| † | K253370 | LOGIQ Totus | 2026 |
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 12 months on median.
- 50 of the 156 ancestors have a recall of any class.
- 1 other device also cites its predicate K253366.
How does its category compare?
All IYN devicesIYN System, Imaging, Pulsed Doppler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · IYN
57in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYN
124in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYN
10in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · IYN
610in 2025
MAUDE reports naming product code IYN, 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 | 13 | 26 | 16 | 3 |
| 2008 | 25 | 18 | 12 | 2 |
| 2009 | 18 | 29 | 8 | 9 |
| 2010 | 29 | 67 | 10 | 17 |
| 2011 | 39 | 46 | 8 | 18 |
| 2012 | 43 | 37 | 3 | 20 |
| 2013 | 51 | 60 | 8 | 18 |
| 2014 | 56 | 39 | 2 | 48 |
| 2015 | 54 | 55 | 3 | 116 |
| 2016 | 60 | 56 | 2 | 145 |
| 2017 | 64 | 83 | 0 | 146 |
| 2018 | 59 | 85 | 7 | 85 |
| 2019 | 47 | 79 | 0 | 59 |
| 2020 | 57 | 72 | 4 | 67 |
| 2021 | 46 | 105 | 8 | 213 |
| 2022 | 53 | 105 | 10 | 186 |
| 2023 | 44 | 115 | 4 | 229 |
| 2024 | 50 | 119 | 1 | 266 |
| 2025 | 57 | 124 | 10 | 610 |
| 2026 | 44 | 107 | 2 (1) | — |
What is it indicated for?
LOGIQ Focus is a general-purpose diagnostic ultrasound system intended for qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. The system is intended for use for the following Part of Body or Type of Tissue: Fetal/Obstetrical, Abdominal (including Renal, Gynecology/Pelvic, Thoracic/Pleural), Pediatric, Small Organ (Breast, Testes, Thyroid), Neonatal Cephalic, Adult…
Read the full statement (141 words)
LOGIQ Focus is a general-purpose diagnostic ultrasound system intended for qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid.
The system is intended for use for the following Part of Body or Type of Tissue: Fetal/Obstetrical,
Abdominal (including Renal, Gynecology/Pelvic, Thoracic/Pleural), Pediatric, Small Organ (Breast, Testes, Thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (Adult and Pediatric), Peripheral Vascular,
Musculoskeletal Conventional and Superficial, Urology (including prostate), Transrectal, Transvaginal,
Transesophageal and Intraoperative (Vascular), Interventional Guidance (including tissue biopsy, fluid drainage, vascular and nonvascular access).
Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power
Doppler, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography, Shear Wave Elastography,
Attenuation Imaging and Combined modes: B/M, B/Color, B/PWD, B/Color/PWD, B/Power/PWD.
LOGIQ Focus is intended to be used in a hospital or medical clinic.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K261835 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261835: LOGIQ Focus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261835
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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