510(k) · Cleared
ClearedVingmed Sound Color Flow Mapping System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diasonics, Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Jan 2, 1997 as substantially equivalent to K921750 (Cardiovascular Imaging Systems, Inc., 1992) after a 178-day review. Its family tree reaches back 1 generation to 1992. 3 later devices descend from it.
- Decided
- Jan 2, 1997
- Review
- 178 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K921750 (1992). 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK921750 Cvis Insight Iii SystemCardiovascular Imaging Systems, Inc. · 1992
- This deviceK962662 Vingmed Sound Color Flow Mapping SystemDiasonics, Inc. · 1997
- Descendant · cites it directly · 2 of its ownK972973 Perception Inc. GPS-Tuv Diagnostic Ultrasound SystemPerception, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK981834 Perception Inc, GPS-6TBMD Diagnostic Ultrasound SystemPerception, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK974880 Perception GPS-RST Diagnostic Ultrasound SystemPerception, Inc. · 1998
Most influential descendants
Showing 3 of 3 · See all- K972973Perception Inc. GPS-Tuv Diagnostic Ultrasound SystemPerception, Inc. · 1997 · cites it directly2descendants
- K981834Perception Inc, GPS-6TBMD Diagnostic Ultrasound SystemPerception, Inc. · 1998 · cites it directly0descendants
- K974880Perception GPS-RST Diagnostic Ultrasound SystemPerception, Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K921750 | Cvis Insight Iii System | Cardiovascular Imaging Systems, Inc. | 1992 | — |
| 0 (this device) | K962662 | Vingmed Sound Color Flow Mapping System | Diasonics, Inc. | 1997 | — |
| +1 | K972973 | Perception Inc. GPS-Tuv Diagnostic Ultrasound System | Perception, Inc. | 1997 | — |
| +1 | K981834 | Perception Inc, GPS-6TBMD Diagnostic Ultrasound System | Perception, Inc. | 1998 | — |
| +1 | K974880 | Perception GPS-RST Diagnostic Ultrasound System | Perception, Inc. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 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? (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 |
|---|---|---|---|
| * | K921750 | Cvis Insight Iii SystemSummary page 1…pared: 19. June 1996 2: Device Name: Intra Vascular Ultrasound System (IVUS) option for Vingmed Sound Color Flow Mapping System 3: Predicate Device: CVIS Insight III, K921750 4: Device Description: The IVUS consists of a basic scanner unit integrated into the CFM 775/800 ultrasound system. The basic s… | 1992 |
What descends from it? (3)
3 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?
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?
The IVUS option for the CFM product family is intended for intravascular applications at all system control settings. When used with a Vingmed Color Flow Mapping (CFM) imaging system the device can be used to obtain, store and retrieve 2D images and perform measurements and analysis on these. The IVUS option is intended for use by duly licensed physician who has received appropriate training in proper operation of the device. As with any procedure of…
Read the full statement (174 words)
The IVUS option for the CFM product family is intended for intravascular applications at all system control settings. When used with a Vingmed Color Flow Mapping (CFM) imaging system the device can be used to obtain, store and retrieve 2D images and perform measurements and analysis on these.
The IVUS option is intended for use by duly licensed physician who has received appropriate training in proper operation of the device.
As with any procedure of this sort, the physician conducting the examination must exercise sound medical judgment in the selection of patients for this product, and be skilled in interpreting the echocardiographic data obtained from intra-vascular ultrasound devices.
The IVUS option is intended to be used with a Vingmed Color Flow Mapping (CFM) imaging system to apply ultrasound energy from an intra-vascular catheter to:
Produce 2D images that can be used to detect abnormalities.
Store images in the CFM system or via the CFM system to other storage media.
Images can be retrieved from the CFM system or storage media for measurement and analysis.
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/K962662 · printed Nov 4, 2026
Cite this page
510(k) Report. “K962662: Vingmed Sound Color Flow Mapping System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962662
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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