510(k) · Cleared
Cleared7200 Ultrasound Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biosound Esaote, Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Jun 30, 1998 as substantially equivalent to K944287 (Biosound, Inc., 1995) after an 82-day review. Its family tree reaches back 1 generation to 1995. 2 of the 115 devices in its family, counting itself, have a Class I recall. 113 later devices descend from it.
- Decided
- Jun 30, 1998
- Review
- 82 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K944287 (1995). 113 later devices descend from it, 1 citing it directly. 2 of the 115 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK944287 7050 Ultrasound Imaging SystemBiosound, Inc. · 1995
- This deviceK981293 7200 Ultrasound Imaging SystemBiosound Esaote, Inc. · 1998
- Descendant · cites it directly · 112 of its ownK020112 50S Tringa Ultrasound Imaging SystemPie Medical · 2002
- Descendant · 2 generations on · 107 of its ownK090505 Speq Ultrasound SystemSignostics Pty, Ltd. · 2009
- Descendant · 3 generations on · 103 of its ownK102153 Mobius Ultrasound Imaging SystemMobisante, Inc. · 2011
- Descendant · 4 generations on · 87 of its ownK133833 Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2014 · Recalled
- Descendant · 5 generations on · 79 of its ownK152899 Philips Lumify Diagnostic Ultrasound SystemPhilips Healthcare, Inc. · 2015 · Recalled
Showing 5 of 113 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 113 · See all- K02011250S Tringa Ultrasound Imaging SystemPie Medical · 2002 · cites it directly112descendants
- K090505Speq Ultrasound SystemSignostics Pty, Ltd. · 2009 · 2 generations on107descendants
- K102153Mobius Ultrasound Imaging SystemMobisante, Inc. · 2011 · 3 generations on103descendants
- K133833Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2014 · 4 generations on87descendants
- K152899Philips Lumify Diagnostic Ultrasound SystemPhilips Healthcare, Inc. · 2015 · 5 generations on79descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K944287 | 7050 Ultrasound Imaging System | Biosound, Inc. | 1995 | — |
| 0 (this device) | K981293 | 7200 Ultrasound Imaging System | Biosound Esaote, Inc. | 1998 | — |
| +1 | K020112 | 50S Tringa Ultrasound Imaging System | Pie Medical | 2002 | — |
| +2 | K090505 | Speq Ultrasound System | Signostics Pty, Ltd. | 2009 | — |
| +3 | K102153 | Mobius Ultrasound Imaging System | Mobisante, Inc. | 2011 | — |
| +4 | K133833 | Nuvis Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2014 | 3 |
| +5 | K152899 | Philips Lumify Diagnostic Ultrasound System | Philips Healthcare, Inc. | 2015 | 4 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 5 | 0 |
| 2016 | 5 | 0 |
| 2017 | 7 | 0 |
| 2018 | 5 | 0 |
| 2019 | 3 | 0 |
| 2020 | 8 | 0 |
| 2021 | 12 | 0 |
| 2022 | 9 | 0 |
| 2023 | 7 | 0 |
| 2024 | 9 | 0 |
| 2025 | 15 | 2 |
| 2026 | 16 | 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.
2 devices in this family have a Class I recall. 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 IYO device
- #1 K243937 Accuro 3Sscore 20.5 · 18 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 |
|---|---|---|---|
| * | K944287 | 7050 Ultrasound Imaging SystemSummary page 1…ed doppler imaging system 892.1550 Ultrasonic pulsed echo imaging system 892.1560 Classification Number: 90IYN 90IYO 807.92(aX3) Predicate Device(s) Esaote 7050 (AU3) K944287 Additional Substantial Equivalence Information is provided in the following substantial Equivalence Comparison Table. === Page… | 1995 |
| † | K913209 | Accessory to Genesis Iii (GCFM) | 1992 |
| † | K953579 | Tee Probe | 1996 |
What descends from it? (113)
See all 1131 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K020112 | 50S Tringa Ultrasound Imaging System | 2002 | 112 |
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
What does this lineage say?
How does its category compare?
All IYO devicesIYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IYO
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYO
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYO
485in 2025
MAUDE reports naming product code IYO, 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 | 20 | 17 | 4 | 39 |
| 2008 | 14 | 36 | 5 | 20 |
| 2009 | 13 | 79 | 9 | 27 |
| 2010 | 15 | 113 | 8 | 20 |
| 2011 | 11 | 69 | 0 | 58 |
| 2012 | 15 | 68 | 2 | 78 |
| 2013 | 17 | 50 | 3 | 436 |
| 2014 | 14 | 63 | 2 | 304 |
| 2015 | 19 | 46 | 1 | 268 |
| 2016 | 10 | 36 | 0 | 254 |
| 2017 | 19 | 72 | 0 | 238 |
| 2018 | 14 | 56 | 1 | 368 |
| 2019 | 13 | 59 | 1 | 537 |
| 2020 | 11 | 57 | 0 | 498 |
| 2021 | 15 | 64 | 11 | 617 |
| 2022 | 5 | 190 | 1 | 511 |
| 2023 | 11 | 177 | 0 | 527 |
| 2024 | 10 | 220 | 0 | 640 |
| 2025 | 7 | 171 | 0 | 485 |
| 2026 | 10 | 139 | 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981293 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981293: 7200 Ultrasound Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981293
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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