510(k) · Cleared
ClearedAida VI.8 Diagnostic Ultrasound GM-72P00A, L13-5V1 Transducer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Panasonic Healthcare Co., Ltd. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Oct 3, 2012 as substantially equivalent to K113612 (Panasonic Healthcare Co., Ltd., 2012) and 1 other predicate after an 86-day review. Its family tree reaches back 15 generations to 1989.
- Decided
- Oct 3, 2012
- Review
- 86 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 15 generations to K894632 (1989). 93 ancestors in all. No later device cites it as a predicate yet.
- Root · 15 generations backK894632 Model SSH-140A Ultrasound Imaging SystemToshiba America Medical Systems, In.C · 1989
- 11 generations between
- 3 generations backK093171 Viamo Ssa-640A Version 1.2Toshiba America Medical Systems, In.C · 2009
- 2 generations backK103148 Aida Diagnostic Ultrasound SystemPanasonic Healthcare Co., Ltd. · 2011
- 1 generation backK113612 Aida V1.5 Diagnostic Ultrasound System GM-72P00APanasonic Healthcare Co., Ltd. · 2012
- This deviceK122009 Aida VI.8 Diagnostic Ultrasound GM-72P00A, L13-5V1 TransducerPanasonic Healthcare Co., Ltd. · 2012
Show all 15 generations
- Root · 15 generations backK894632 Model SSH-140A Ultrasound Imaging SystemToshiba America Medical Systems, In.C · 1989
- 14 generations backK941593 Diagnostic Ultrasonic TransducerToshiba America Medical Systems, In.C · 1996
- 13 generations backK970047 Phased Array Transducer - - PSK-20CTToshiba America Medical Systems, In.C · 1997
- 12 generations backK991858 Ssa-390A/Power Vision 8000Toshiba America Medical Systems, In.C · 1999
- 11 generations backK013633 Ssa-770A, Aplio Ultrasound SystemToshiba America Medical Systems, In.C · 2001
- 10 generations backK022400 Ssa-700A, Aplio Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C · 2002 · Recalled
- 9 generations backK032281 Ssa-770A - Version 4, Aplio Diagnostic Ultrasound SystemToshiba America Medical Systems, In.C · 2003
- 8 generations backK063130 Aplio XG Diagnostic Ultrasound System, Model Ssa-790A, Version 1.0Toshibamedical Systems Corporation · 2006 · Recalled
- 7 generations backK072000 Aplio XG Diagnostic Ultrasound System, Model Ssa-790A Version 2.0Toshiba America Medical Systems, In.C · 2007
- 6 generations backK081065 Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A, Version 2.2Toshiba America Medical Systems, In.C · 2008
- 5 generations backK082119 Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A Version 3.0Toshiba America Medical Systems, In.C · 2008
- 4 generations backK091295 Aplio XG Diagnostic Ultrasound System Model Ssa-790A Version 4.0Toshiba America Medical Systems, In.C · 2009 · Recalled
- 3 generations backK093171 Viamo Ssa-640A Version 1.2Toshiba America Medical Systems, In.C · 2009
- 2 generations backK103148 Aida Diagnostic Ultrasound SystemPanasonic Healthcare Co., Ltd. · 2011
- 1 generation backK113612 Aida V1.5 Diagnostic Ultrasound System GM-72P00APanasonic Healthcare Co., Ltd. · 2012
- This deviceK122009 Aida VI.8 Diagnostic Ultrasound GM-72P00A, L13-5V1 TransducerPanasonic Healthcare Co., Ltd. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K894632 | Model SSH-140A Ultrasound Imaging System | Toshiba America Medical Systems, In.C | 1989 | — |
| −14 | K941593 | Diagnostic Ultrasonic Transducer | Toshiba America Medical Systems, In.C | 1996 | — |
| −13 | K970047 | Phased Array Transducer - - PSK-20CT | Toshiba America Medical Systems, In.C | 1997 | — |
| −12 | K991858 | Ssa-390A/Power Vision 8000 | Toshiba America Medical Systems, In.C | 1999 | — |
| −11 | K013633 | Ssa-770A, Aplio Ultrasound System | Toshiba America Medical Systems, In.C | 2001 | — |
| −10 | K022400 | Ssa-700A, Aplio Diagnostic Ultrasound System | Toshiba America Medical Systems, In.C | 2002 | 1 |
| −9 | K032281 | Ssa-770A - Version 4, Aplio Diagnostic Ultrasound System | Toshiba America Medical Systems, In.C | 2003 | — |
| −8 | K063130 | Aplio XG Diagnostic Ultrasound System, Model Ssa-790A, Version 1.0 | Toshibamedical Systems Corporation | 2006 | 1 |
| −7 | K072000 | Aplio XG Diagnostic Ultrasound System, Model Ssa-790A Version 2.0 | Toshiba America Medical Systems, In.C | 2007 | — |
| −6 | K081065 | Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A, Version 2.2 | Toshiba America Medical Systems, In.C | 2008 | — |
| −5 | K082119 | Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A Version 3.0 | Toshiba America Medical Systems, In.C | 2008 | — |
| −4 | K091295 | Aplio XG Diagnostic Ultrasound System Model Ssa-790A Version 4.0 | Toshiba America Medical Systems, In.C | 2009 | 2 |
| −3 | K093171 | Viamo Ssa-640A Version 1.2 | Toshiba America Medical Systems, In.C | 2009 | — |
| −2 | 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 | — |
| 0 (this device) | 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 |
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? (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 |
|---|---|---|---|
| * | K113612 | Aida V1.5 Diagnostic Ultrasound System GM-72P00ASummary page 1…nsducer (21 CFR 892.1570) Classification Number(s): 90-IYN; 90-IVO; 90-ITX Regulatory Class: Class 11 Predicate Device(s): K113612 -AIDA V1.5 Diagnostic Ultrasound System GM-72P00A, Panasonic Healthcare Co., Ltd… | 2012 |
| * | K093171 | Viamo Ssa-640A Version 1.2Summary page 1…K113612 -AIDA V1.5 Diagnostic Ultrasound System GM-72P00A, Panasonic Healthcare Co., Ltd K093171 - Viamo SSA-640A, Toshiba America Medical Systems, Inc.… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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 23 years and passes through 3 companies; a new generation was cleared every 10 months on median.
- 14 of the 93 ancestors have a recall of any class.
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. 2012, 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 AIDA V1.8 Diagnostic Ultrasound System GM-72P00A is intended for Peripheral Vessel application. The system provides ultrasound imaging information such as the visualization of anatomical structures, characteristics and dynamic processes within the human body using ultrasound to aid diagnosis. The AIDA V1.8 Diagnostic Ultrasound System GM-72P00A also provides an automated intima-media thickness measurement of peripheral vessels such as the common carotid in the BIMT-modeof operation for heart rate range of 20-150 beats per minute. This system is contraindicated for fetal use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122009 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122009: Aida VI.8 Diagnostic Ultrasound GM-72P00A, L13-5V1 Transducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122009
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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