510(k) · Cleared
ClearedAida Diagnostic Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Panasonic Healthcare Co., Ltd. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Mar 11, 2011 as substantially equivalent to K093171 (Toshiba America Medical Systems, In.C, 2009) and 2 other predicates after a 137-day review. Its family tree reaches back 13 generations to 1989. 2 later devices descend from it.
- Decided
- Mar 11, 2011
- Review
- 137 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 13 generations to K894632 (1989). 91 ancestors in all. 2 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 backK093171 Viamo Ssa-640A Version 1.2Toshiba America Medical Systems, In.C · 2009
- This deviceK103148 Aida Diagnostic Ultrasound SystemPanasonic Healthcare Co., Ltd. · 2011
- Descendant · cites it directly · 1 of its ownK113612 Aida V1.5 Diagnostic Ultrasound System GM-72P00APanasonic Healthcare Co., Ltd. · 2012
- Descendant · 2 generations on · 0 of its ownK122009 Aida VI.8 Diagnostic Ultrasound GM-72P00A, L13-5V1 TransducerPanasonic Healthcare Co., Ltd. · 2012
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 backK093171 Viamo Ssa-640A Version 1.2Toshiba America Medical Systems, In.C · 2009
- This deviceK103148 Aida Diagnostic Ultrasound SystemPanasonic Healthcare Co., Ltd. · 2011
Most influential descendants
Showing 2 of 2 · See allView 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 | K093171 | Viamo Ssa-640A Version 1.2 | Toshiba America Medical Systems, In.C | 2009 | — |
| 0 (this device) | K103148 | Aida Diagnostic Ultrasound System | Panasonic Healthcare Co., Ltd. | 2011 | — |
| +1 | K113612 | Aida V1.5 Diagnostic Ultrasound System GM-72P00A | Panasonic Healthcare Co., Ltd. | 2012 | — |
| +2 | K122009 | Aida VI.8 Diagnostic Ultrasound GM-72P00A, L13-5V1 Transducer | Panasonic Healthcare Co., Ltd. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 5 | 0 |
| 1995 | 7 | 0 |
| 1996 | 2 | 0 |
| 1997 | 7 | 0 |
| 1998 | 7 | 0 |
| 1999 | 11 | 0 |
| 2000 | 6 | 0 |
| 2001 | 2 | 0 |
| 2002 | 5 | 0 |
| 2003 | 6 | 0 |
| 2004 | 7 | 0 |
| 2005 | 6 | 0 |
| 2006 | 3 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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 IYO? 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K093171 | Viamo Ssa-640A Version 1.2Summary page 1…nostic Ultrasound Transducer (21 CFR 892.1570) Classification Number(s): 90-IVO; 90-ITX Regulatory Class: Class 11 Predicate Device(s): K093171 - 7 Viamo SSA-640A, Toshiba America Medical Systems, Inc. K081794… | 2009 |
| * | K081794 | Model 7340 Ultrasound SystemSummary page 1…ass 11 Predicate Device(s): K093171 - 7 Viamo SSA-640A, Toshiba America Medical Systems, Inc. K081794 - 7340 Ultrasound System, Esaote, Sp.A. K022567 - Sequoia Diagnostic Ultrasound System, Acuson Co… | 2008 |
| * | K022567 | Sequoia Signature II Diagnostic Ultrasound SystemSummary page 1…ica Medical Systems, Inc. K081794 - 7340 Ultrasound System, Esaote, Sp.A. K022567 - Sequoia Diagnostic Ultrasound System, Acuson Corp. Device Description: The AIDA diagnostic ul… | 2002 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113612 | Aida V1.5 Diagnostic Ultrasound System GM-72P00A | 2012 | 1 |
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 3 companies; a new generation was cleared every 10 months on median.
- 14 of the 91 ancestors have a recall of any class.
- Of its descendants, K113612 (Panasonic Healthcare Co., Ltd., 2012) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K093171.
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. 2011, this device’s year, is highlighted.
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?
The AIDA diagnostic ultrasound system is intended for Peripheral Vessel applications. The system provides an automated intima-media thickness measurement of peripheral vessels such as the common carotid in the BIMT mode of operation for heart rate range of 20-150 beats per minute. The AIDA ultrasound system is contraindicated for fetal use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103148 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103148: Aida Diagnostic Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103148
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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