510(k) · Cleared
ClearedGE Logiq 7 Ultrasound BT05
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
General Electric Co. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Sep 21, 2005 as substantially equivalent to K032182 (General Electric Co., 2003) and 1 other predicate after a 15-day review. Its family tree reaches back 3 generations to 2001. 629 later devices descend from it.
- Decided
- Sep 21, 2005
- Review
- 15 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K010329 (2001). 629 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK010329 LOGIQ 500General Electric Co. · 2001
- 2 generations backK032182 GE Logiq 7, Model 2354858General Electric Co. · 2003
- 1 generation backK041813 GE Logiq 7 Ultrasound BT04Ge Medical Systems Ultrasound and Primary Care Dia · 2004
- This deviceK052441 GE Logiq 7 Ultrasound BT05General Electric Co. · 2005
- Descendant · cites it directly · 628 of its ownK073408 GE Logiq BT08 Diagnostic Ultrasound SystemGe Medical Systems Ultrasound and Primary Care Dia · 2007
- Descendant · 2 generations on · 627 of its ownK082185 GE Logiq E9 Diagnostic Ultrasound System, Models 5205000, 5205000-2Ge Medical Systems Ultrasound and Primary Care Dia · 2008 · Recalled
- Descendant · 3 generations on · 569 of its ownK092271 GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3…GE Healthcare · 2009 · Recalled
- Descendant · cites it directly · 472 of its ownK110943 Logiq E9GE Healthcare · 2011 · Recalled
- Descendant · 2 generations on · 469 of its ownK113690 GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · Recalled
Showing 5 of 629 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 629 · See all- K073408GE Logiq BT08 Diagnostic Ultrasound SystemGe Medical Systems Ultrasound and Primary Care Dia · 2007 · cites it directly628descendants
- K082185GE Logiq E9 Diagnostic Ultrasound System, Models 5205000, 5205000-2Ge Medical Systems Ultrasound and Primary Care Dia · 2008 · 2 generations on627descendants
- K092271GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4GE Healthcare · 2009 · 3 generations on569descendants
- K110943Logiq E9GE Healthcare · 2011 · cites it directly472descendants
- K113690GE Logiq I, Logiq E and Vivid EGE Healthcare · 2011 · 2 generations on469descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K010329 | LOGIQ 500 | General Electric Co. | 2001 | — |
| −2 | K032182 | GE Logiq 7, Model 2354858 | General Electric Co. | 2003 | — |
| −1 | K041813 | GE Logiq 7 Ultrasound BT04 | Ge Medical Systems Ultrasound and Primary Care Dia | 2004 | — |
| 0 (this device) | K052441 | GE Logiq 7 Ultrasound BT05 | General Electric Co. | 2005 | — |
| +1 | K073408 | GE Logiq BT08 Diagnostic Ultrasound System | Ge Medical Systems Ultrasound and Primary Care Dia | 2007 | — |
| +2 | K082185 | GE Logiq E9 Diagnostic Ultrasound System, Models 5205000, 5205000-2 | Ge Medical Systems Ultrasound and Primary Care Dia | 2008 | 1 |
| +3 | K092271 | GE Logiq E9 BT2010 Diagnostic Ultrasound System, Model 5205000-3, 5205000-4 | GE Healthcare | 2009 | 1 |
| +1 | K110943 | Logiq E9 | GE Healthcare | 2011 | 2 |
| +2 | K113690 | GE Logiq I, Logiq E and Vivid E | GE Healthcare | 2011 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 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? (3)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K011032 | FDA’s K011032 is Smartjet Bone Graft Liquid Applicator (Spray Tip), Model SK/S, Smartjet Bone… Our reading of the summary gave K011032, FDA’s number for Smartjet Bone Graft Liquid Applicator (Spray Tip), Model… (Harvest Technologies, Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “GE LOGIQ 7 Diagnostic Ultrasound System”. Kept off the family tree. Summary page 1…892.1560, 90-IYO Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYN 3. Marketed Device: GE LOGIG 7 Diagnostic Ultrasound System K0110329, K032182, K041813 A device currently in commercial distribution. 4. Devce esripio: The GE LOGIQ 7 is afu… | 2001 |
| * | K032182 | GE Logiq 7, Model 2354858Summary page 1…90-IYO Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYN 3. Marketed Device: GE LOGIG 7 Diagnostic Ultrasound System K0110329, K032182, K041813 A device currently in commercial distribution. 4. Devce esripio: The GE LOGIQ 7 is afull feature… | 2003 |
| * | K041813 | GE Logiq 7 Ultrasound BT04Summary page 1…Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYN 3. Marketed Device: GE LOGIG 7 Diagnostic Ultrasound System K0110329, K032182, K041813 A device currently in commercial distribution. 4. Devce esripio: The GE LOGIQ 7 is afull featured general… | 2004 |
What descends from it? (629)
See all 6293 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 4 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K073408 (Ge Medical Systems Ultrasound and Primary Care Dia, 2007) has gone furthest, with 628 descendants of its own.
- 2 other devices also cite its predicate K032182.
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.
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?
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052441 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052441: GE Logiq 7 Ultrasound BT05.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052441
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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