510(k) · Cleared
ClearedPet-512MC Transesophageal Transducer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Toshiba America Medical Systems, In.C · ITX Transducer, Ultrasonic, Diagnostic
Cleared on Feb 2, 2011 as substantially equivalent to K092179 (Toshiba America Medical Systems, In.C, 2009) and 1 other predicate after a 51-day review. Its family tree reaches back 13 generations to 1989. 6 later devices descend from it.
- Decided
- Feb 2, 2011
- Review
- 51 days
- Class
- Class II
- Product code
- ITX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K894632 (1989). 113 ancestors in all. 6 later devices descend from it, 1 citing it directly.
- Root · 13 generations backK894632 Model SSH-140A Ultrasound Imaging SystemToshiba America Medical Systems, In.C · 1989
- 9 generations between
- 3 generations backK082119 Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A Version 3.0Toshiba America Medical Systems, In.C · 2008
- 2 generations backK091295 Aplio XG Diagnostic Ultrasound System Model Ssa-790A Version 4.0Toshiba America Medical Systems, In.C · 2009 · Recalled
- 1 generation backK092179 Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A Version…Toshiba America Medical Systems, In.C · 2009 · Recalled
- This deviceK103629 Pet-512MC Transesophageal TransducerToshiba America Medical Systems, In.C · 2011
- Descendant · cites it directly · 5 of its ownK161960 bk2300Bk Medical Aps · 2016
- Descendant · 2 generations on · 2 of its ownK180737 Ultrasound Scanner System bk2300Bk Medical Aps · 2018
- Descendant · 3 generations on · 1 of its ownK222441 Ultrasound System 2300Bk Medical Aps · 2022
- Descendant · 2 generations on · 1 of its ownK173569 Ultrasound System 1300Bk Medical Aps · 2018
- Descendant · 3 generations on · 0 of its ownK231764 Ultrasound System 1300Bk Medical Aps · 2023 · Recalled
Show all 13 generations
- Root · 13 generations backK894632 Model SSH-140A Ultrasound Imaging SystemToshiba America Medical Systems, In.C · 1989
- 12 generations backK941593 Diagnostic Ultrasonic TransducerToshiba America Medical Systems, In.C · 1996
- 11 generations backK970047 Phased Array Transducer - - PSK-20CTToshiba America Medical Systems, In.C · 1997
- 10 generations backK991858 Ssa-390A/Power Vision 8000Toshiba America Medical Systems, In.C · 1999
- 9 generations backK013633 Ssa-770A, Aplio Ultrasound SystemToshiba America Medical Systems, In.C · 2001
- 8 generations backK022400 Ssa-700A, Aplio Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C · 2002 · Recalled
- 7 generations backK032281 Ssa-770A - Version 4, Aplio Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C · 2003
- 6 generations backK063130 Aplio XG Diagnostic Ultrasound System, Model Ssa-790A, Version 1.0Toshibamedical Systems Corporation · 2006 · Recalled
- 5 generations backK072000 Aplio XG Diagnostic Ultrasound System, Model Ssa-790A Version 2.0Toshiba America Medical Systems, In.C · 2007
- 4 generations backK081065 Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A, Version 2.2Toshiba America Medical Systems, In.C · 2008
- 3 generations backK082119 Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A Version 3.0Toshiba America Medical Systems, In.C · 2008
- 2 generations backK091295 Aplio XG Diagnostic Ultrasound System Model Ssa-790A Version 4.0Toshiba America Medical Systems, In.C · 2009 · Recalled
- 1 generation backK092179 Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A Version…Toshiba America Medical Systems, In.C · 2009 · Recalled
- This deviceK103629 Pet-512MC Transesophageal TransducerToshiba America Medical Systems, In.C · 2011
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K161960bk2300Bk Medical Aps · 2016 · cites it directly5descendants
- K180737Ultrasound Scanner System bk2300Bk Medical Aps · 2018 · 2 generations on2descendants
- K222441Ultrasound System 2300Bk Medical Aps · 2022 · 3 generations on1descendant
- K173569Ultrasound System 1300Bk Medical Aps · 2018 · 2 generations on1descendant
- K231764Ultrasound System 1300Bk Medical Aps · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K894632 | Model SSH-140A Ultrasound Imaging System | Toshiba America Medical Systems, In.C | 1989 | — |
| −12 | K941593 | Diagnostic Ultrasonic Transducer | Toshiba America Medical Systems, In.C | 1996 | — |
| −11 | K970047 | Phased Array Transducer - - PSK-20CT | Toshiba America Medical Systems, In.C | 1997 | — |
| −10 | K991858 | Ssa-390A/Power Vision 8000 | Toshiba America Medical Systems, In.C | 1999 | — |
| −9 | K013633 | Ssa-770A, Aplio Ultrasound System | Toshiba America Medical Systems, In.C | 2001 | — |
| −8 | K022400 | Ssa-700A, Aplio Diagnostic Ultrasound System | Toshiba America Medical Systems, In.C | 2002 | 1 |
| −7 | K032281 | Ssa-770A - Version 4, Aplio Diagnostic Ultrasound System | Toshiba America Medical Systems, In.C | 2003 | — |
| −6 | K063130 | Aplio XG Diagnostic Ultrasound System, Model Ssa-790A, Version 1.0 | Toshibamedical Systems Corporation | 2006 | 1 |
| −5 | K072000 | Aplio XG Diagnostic Ultrasound System, Model Ssa-790A Version 2.0 | Toshiba America Medical Systems, In.C | 2007 | — |
| −4 | K081065 | Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A, Version 2.2 | Toshiba America Medical Systems, In.C | 2008 | — |
| −3 | K082119 | Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A Version 3.0 | Toshiba America Medical Systems, In.C | 2008 | — |
| −2 | K091295 | Aplio XG Diagnostic Ultrasound System Model Ssa-790A Version 4.0 | Toshiba America Medical Systems, In.C | 2009 | 2 |
| −1 | K092179 | Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A Version 4.0R001 | Toshiba America Medical Systems, In.C | 2009 | 1 |
| 0 (this device) | K103629 | Pet-512MC Transesophageal Transducer | Toshiba America Medical Systems, In.C | 2011 | — |
| +1 | K161960 | bk2300 | Bk Medical Aps | 2016 | — |
| +2 | K180737 | Ultrasound Scanner System bk2300 | Bk Medical Aps | 2018 | — |
| +3 | K222441 | Ultrasound System 2300 | Bk Medical Aps | 2022 | — |
| +2 | K173569 | Ultrasound System 1300 | Bk Medical Aps | 2018 | — |
| +3 | K231764 | Ultrasound System 1300 | Bk Medical Aps | 2023 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 6 | 0 |
| 1995 | 8 | 0 |
| 1996 | 2 | 0 |
| 1997 | 8 | 0 |
| 1998 | 3 | 0 |
| 1999 | 10 | 0 |
| 2000 | 6 | 0 |
| 2001 | 5 | 0 |
| 2002 | 7 | 0 |
| 2003 | 7 | 0 |
| 2004 | 14 | 0 |
| 2005 | 9 | 0 |
| 2006 | 5 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 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 ITX? 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 ITX device
- #1 K260114 Align® Cover and Pad Guidance Toolscore 13.6 · 6 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 |
|---|---|---|---|
| * | K092179 | Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A Version 4.0R001Summary page 1…ems believes that this device is substantially equivalent to: * Toshiba APL1O XG Diagnostic Ultrasound System MODEL SSA-790A V4.0 ROOQ1, PET- 510OMB - 5 10(k) K092179 " Zonare Medical Systems Inc., z.one Ultra P8-3T - 5 10O(k) K 10 1091 Device Description: The PET-5 12MC is a multipla… | 2009 |
| * | K101091 | Z.One Ultra Ultrasound SystemSummary page 1…hiba APL1O XG Diagnostic Ultrasound System MODEL SSA-790A V4.0 ROOQ1, PET- 510OMB - 5 10(k) K092179 " Zonare Medical Systems Inc., z.one Ultra P8-3T - 5 10O(k) K 10 1091 Device Description: The PET-5 12MC is a multiplane transesophageal transducer (TEE) designed for use with Toshiba Diagn… | 2010 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161960 | bk2300 | 2016 | 5 |
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 22 years and passes through 2 companies; a new generation was cleared every 10 months on median.
- 26 of the 113 ancestors have a recall of any class.
- Of its descendants, K161960 (Bk Medical Aps, 2016) has gone furthest, with 5 descendants of its own.
- 2 other devices also cite its predicate K092179.
How does its category compare?
All ITX devicesITX Transducer, Ultrasonic, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · ITX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ITX
126in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ITX
2in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · ITX
571in 2025
MAUDE reports naming product code ITX, 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 | 10 | 26 | 0 | 16 |
| 2008 | 12 | 73 | 4 | 39 |
| 2009 | 17 | 28 | 4 | 23 |
| 2010 | 10 | 42 | 4 | 30 |
| 2011 | 10 | 16 | 1 | 34 |
| 2012 | 7 | 25 | 1 | 29 |
| 2013 | 3 | 105 | 0 | 38 |
| 2014 | 4 | 41 | 1 | 43 |
| 2015 | 1 | — | 5 | 183 |
| 2016 | 4 | 151 | 0 | 269 |
| 2017 | 6 | 110 | 1 | 412 |
| 2018 | 2 | — | 15 | 130 |
| 2019 | 1 | — | 0 | 119 |
| 2020 | 3 | 120 | 3 | 116 |
| 2021 | 3 | 139 | 10 (10) | 146 |
| 2022 | 2 | — | 6 | 87 |
| 2023 | 6 | 213 | 1 | 138 |
| 2024 | 3 | 81 | 1 | 988 |
| 2025 | 4 | 126 | 2 | 571 |
| 2026 | 6 | 158 | 0 | — |
What is it indicated for?
The PET-512MC is a transesophageal transducer (TEE) designed for use with Toshiba Diagnostic Ultrasound System for the visualization of the heart (and other organs) as a real-time ultrasound image. It is inserted into the esophagus through the mouth to visualize a plane of the heart through the esophageal wall.
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/K103629 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103629: Pet-512MC Transesophageal Transducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103629
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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