510(k) · Cleared
ClearedGE Logiq BT08 Diagnostic Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems Ultrasound and Primary Care Dia · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Dec 19, 2007 as substantially equivalent to K010329 (General Electric Co., 2001) and 3 other predicates after a 15-day review. Its family tree reaches back 4 generations to 2001. 628 later devices descend from it.
- Decided
- Dec 19, 2007
- Review
- 15 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K010329 (2001). 628 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK010329 LOGIQ 500General Electric Co. · 2001
- 3 generations backK032182 GE Logiq 7, Model 2354858General Electric Co. · 2003
- 2 generations backK041813 GE Logiq 7 Ultrasound BT04Ge Medical Systems Ultrasound and Primary Care Dia · 2004
- 1 generation backK052441 GE Logiq 7 Ultrasound BT05General Electric Co. · 2005
- This deviceK073408 GE Logiq BT08 Diagnostic Ultrasound SystemGe Medical Systems Ultrasound and Primary Care Dia · 2007
- Descendant · cites it directly · 627 of its ownK082185 GE Logiq E9 Diagnostic Ultrasound System, Models 5205000, 5205000-2Ge Medical Systems Ultrasound and Primary Care Dia · 2008 · Recalled
- Descendant · 2 generations on · 569 of its ownK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
- Descendant · 3 generations on · 472 of its ownK110943 Logiq E9GE Healthcare · 2011 · Recalled
- Descendant · 4 generations on · 469 of its ownK113690 GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · Recalled
- Descendant · 3 generations on · 367 of its ownK111582 Logiq S8GE Healthcare · 2011 · Recalled
Showing 5 of 628 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 628 · See all- K082185GE Logiq E9 Diagnostic Ultrasound System, Models 5205000, 5205000-2Ge Medical Systems Ultrasound and Primary Care Dia · 2008 · cites it directly627descendants
- K092271GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4GE Healthcare · 2009 · 2 generations on569descendants
- K110943Logiq E9GE Healthcare · 2011 · 3 generations on472descendants
- K113690GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · 4 generations on469descendants
- K111582Logiq S8GE Healthcare · 2011 · 3 generations on367descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K010329 | LOGIQ 500 | General Electric Co. | 2001 | — |
| −3 | K032182 | GE Logiq 7, Model 2354858 | General Electric Co. | 2003 | — |
| −2 | K041813 | GE Logiq 7 Ultrasound BT04 | Ge Medical Systems Ultrasound and Primary Care Dia | 2004 | — |
| −1 | K052441 | GE Logiq 7 Ultrasound BT05 | General Electric Co. | 2005 | — |
| 0 (this device) | K073408 | GE Logiq BT08 Diagnostic Ultrasound System | Ge Medical Systems Ultrasound and Primary Care Dia | 2007 | — |
| +1 | K082185 | GE Logiq E9 Diagnostic Ultrasound System, Models 5205000, 5205000-2 | Ge Medical Systems Ultrasound and Primary Care Dia | 2008 | 1 |
| +2 | K092271 | GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 | GE Healthcare | 2009 | 1 |
| +3 | K110943 | Logiq E9 | GE Healthcare | 2011 | 2 |
| +4 | K113690 | GE Logiq I, Logiq E and Vivid E | GE Healthcare | 2011 | 1 |
| +3 | K111582 | Logiq S8 | GE Healthcare | 2011 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 5 | 0 |
| 2011 | 13 | 0 |
| 2012 | 23 | 0 |
| 2013 | 25 | 0 |
| 2014 | 36 | 0 |
| 2015 | 32 | 0 |
| 2016 | 43 | 0 |
| 2017 | 55 | 0 |
| 2018 | 53 | 0 |
| 2019 | 38 | 0 |
| 2020 | 53 | 0 |
| 2021 | 39 | 0 |
| 2022 | 45 | 0 |
| 2023 | 41 | 0 |
| 2024 | 45 | 0 |
| 2025 | 47 | 0 |
| 2026 | 31 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K010329 | LOGIQ 500Summary page 1…R 892.1560, 90-IYO Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYN 3. Marketed Device: GE LOGIQ 7 Diagnostic Ultrasound System - K010329, K032182, K041813, K052441. A device currently in commercial distribution. 4. Device Description: The LOGIQ B… | 2001 |
| * | K032182 | GE Logiq 7, Model 2354858Summary page 1…0, 90-IYO Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYN 3. Marketed Device: GE LOGIQ 7 Diagnostic Ultrasound System - K010329, K032182, K041813, K052441. A device currently in commercial distribution. 4. Device Description: The LOGIQ BT08 is a… | 2003 |
| * | K041813 | GE Logiq 7 Ultrasound BT04Summary page 1…Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYN 3. Marketed Device: GE LOGIQ 7 Diagnostic Ultrasound System - K010329, K032182, K041813, K052441. A device currently in commercial distribution. 4. Device Description: The LOGIQ BT08 is a full feat… | 2004 |
| * | K052441 | GE Logiq 7 Ultrasound BT05Summary page 1…onic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYN 3. Marketed Device: GE LOGIQ 7 Diagnostic Ultrasound System - K010329, K032182, K041813, K052441. A device currently in commercial distribution. 4. Device Description: The LOGIQ BT08 is a full featured, general purpose diagnos… | 2005 |
What descends from it? (628)
See all 6281 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082185 | GE Logiq E9 Diagnostic Ultrasound System, Models 5205000, 5205000-2 | 2008 | 627 |
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 6 years and passes through 2 companies; a new generation was cleared every 2.2 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K082185 (Ge Medical Systems Ultrasound and Primary Care Dia, 2008) has gone furthest, with 627 descendants of its own.
- 5 other devices also cite its predicate K010329.
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. 2007, 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?
The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (abdominal, thoracic, vascular and neurosurgical).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073408 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073408: GE Logiq BT08 Diagnostic Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073408
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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