510(k) Report

510(k) · Cleared

Cleared

Perception GPS-RST Diagnostic Ultrasound System

K974880510(k) TraditionalCleared Jun 8, 1998160-day reviewClass II21 CFR 892.1560

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Perception, Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic

Cleared on Jun 8, 1998 as substantially equivalent to K963616 (Aloka Co., Ltd., 1997) and 4 other predicates after a 160-day review. Its family tree reaches back 3 generations to 1992.

Decided
Jun 8, 1998
Review
160 days
Class
Class II
Product code
IYO
Recalls
None
Predicates
5

Its longest line of descent runs back 3 generations to K921750 (1992). 7 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1997: 1 other ancestor1996: 1 other ancestor1993: 1 other ancestor1995: 1 other ancestorK921750 · Cvis Insight Iii System · Cardiovascular Imaging Systems, Inc. · 1992K962662 · Vingmed Sound Color Flow Mapping System · Diasonics, Inc. · 1997K972973 · Perception Inc. GPS-Tuv Diagnostic Ultrasound System · Perception, Inc. · 1997199019921994199619982000
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 1 other ancestor K972973 · Perception Inc. GPS-Tuv Diagnostic Ultrasound System · Perception, Inc. · 1997K962662 · Vingmed Sound Color Flow Mapping System · Diasonics, Inc. · 1997K921750 · Cvis Insight Iii System · Cardiovascular Imaging Systems, Inc. · 19920
  1. Root · 3 generations backK921750 Cvis Insight Iii SystemCardiovascular Imaging Systems, Inc. · 1992
  2. 2 generations backK962662 Vingmed Sound Color Flow Mapping SystemDiasonics, Inc. · 1997
  3. 1 generation backK972973 Perception Inc. GPS-Tuv Diagnostic Ultrasound SystemPerception, Inc. · 1997
  4. This deviceK974880 Perception GPS-RST Diagnostic Ultrasound SystemPerception, Inc. · 1998
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K921750Cvis Insight Iii SystemCardiovascular Imaging Systems, Inc.1992—
−2K962662Vingmed Sound Color Flow Mapping SystemDiasonics, Inc.1997—
−1K972973Perception Inc. GPS-Tuv Diagnostic Ultrasound SystemPerception, Inc.1997—
0 (this device)K974880Perception GPS-RST Diagnostic Ultrasound SystemPerception, Inc.1998—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310
199510
199610
199710
FIG. 1 — Lineage of K974880, 1992–1998Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K243937 Accuro 3Sscore 20.5 · 18 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (5)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K963616Aloka SSD-1700 Diagnostic Ultrasound System
Summary page 1
…mary Prepared: December 5, 1997 2. Name of the Device : Perception GPS-RST Diagnostic Ultrasound System 3. Predicate Device Information : 1. Aloka Co. Model SSD-1700 K963616 2. Diasonics Ultrasound Synergy K935024 Models < CFM800 K924079 EchoPac K962662 3. Perception Inc. . Model GPS-TUV K#972973. -…
Aloka Co., Ltd.1997—
*K935024ESI-5000
Summary page 1
…f the Device : Perception GPS-RST Diagnostic Ultrasound System 3. Predicate Device Information : 1. Aloka Co. Model SSD-1700 K963616 2. Diasonics Ultrasound Synergy K935024 Models < CFM800 K924079 EchoPac K962662 3. Perception Inc. . Model GPS-TUV K#972973. - 4. Device Description : General Descrip…
Elscint, Inc.1996—
*K924079CFM-800 Color Flow Mapping System
Summary page 1
…on GPS-RST Diagnostic Ultrasound System 3. Predicate Device Information : 1. Aloka Co. Model SSD-1700 K963616 2. Diasonics Ultrasound Synergy K935024 Models < CFM800 K924079 EchoPac K962662 3. Perception Inc. . Model GPS-TUV K#972973. - 4. Device Description : General Description The Perception’s G…
Diasonics, Inc.1993—
*K962662Vingmed Sound Color Flow Mapping System
Summary page 1
…ostic Ultrasound System 3. Predicate Device Information : 1. Aloka Co. Model SSD-1700 K963616 2. Diasonics Ultrasound Synergy K935024 Models < CFM800 K924079 EchoPac K962662 3. Perception Inc. . Model GPS-TUV K#972973. - 4. Device Description : General Description The Perception’s GPS-RST Ultrasoun…
Diasonics, Inc.1997—
*K972973Perception Inc. GPS-Tuv Diagnostic Ultrasound System
Summary page 1
…nformation : 1. Aloka Co. Model SSD-1700 K963616 2. Diasonics Ultrasound Synergy K935024 Models < CFM800 K924079 EchoPac K962662 3. Perception Inc. . Model GPS-TUV K#972973. - 4. Device Description : General Description The Perception’s GPS-RST Ultrasound System is a PC (computer) based and control…
Perception, Inc.1997—

Also cleared against K963616: 4 other devices →

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 6 years and passes through 3 companies; a new generation was cleared every 9 months on median.
  • None of the 7 ancestors has a recall.
  • 4 other devices also cite its predicate K963616.

How does its category compare?

All IYO devices

IYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IYO

7in 2025

2007: 202008: 142009: 132010: 152011: 112012: 152013: 172014: 142015: 192016: 102017: 192018: 142019: 132020: 112021: 152022: 52023: 112024: 102025: 72026 (partial year): 10
2007high 20 (2007) · low 5 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYO

171in 2025

2007: 17 days median2008: 36 days median2009: 79 days median2010: 113 days median2011: 69 days median2012: 68 days median2013: 50 days median2014: 63 days median2015: 46 days median2016: 36 days median2017: 72 days median2018: 56 days median2019: 59 days median2020: 57 days median2021: 64 days median2022: 190 days median2023: 177 days median2024: 220 days median2025: 171 days median2026 (partial year): 139 days median
2007high 220 (2024) · low 17 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · IYO

1in 2022

2007: 42008: 52009: 92010: 82012: 22013: 32014: 22015: 12018: 12019: 12021: 112022: 12026 (partial year): 1
2007high 11 (2021) · low 0 (2011)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · IYO

485in 2025

2007: 392008: 202009: 272010: 202011: 582012: 782013: 4362014: 3042015: 2682016: 2542017: 2382018: 3682019: 5372020: 4982021: 6172022: 5112023: 5272024: 6402025: 485
2007high 640 (2024) · low 20 (2008)2025

MAUDE reports naming product code IYO, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072017439
20081436520
20091379927
201015113820
20111169058
20121568278
201317503436
201414632304
201519461268
201610360254
201719720238
201814561368
201913591537
202011570498
2021156411617
202251901511
2023111770527
2024102200640
202571710485
2026101391—

What is it indicated for?

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.

Also cleared against K963616

4 other devices cite the same predicate.

  • K032875Aloka Model SSD-5500 V6.0 Ultrasound SystemAloka Co. Ltd USA · 2003
  • K992663Aloka SSD-5500 Diagnostic Ultrasound SystemAloka Co., Ltd. · 1999
  • K981834Perception Inc, GPS-6TBMD Diagnostic Ultrasound SystemPerception, Inc. · 1998
  • K972973Perception Inc. GPS-Tuv Diagnostic Ultrasound SystemPerception, Inc. · 1997

More from Perception, Inc.

4 FDA decisions under this applicant name. See the company

  • K981834Perception Inc, GPS-6TBMD Diagnostic Ultrasound SystemPerception, Inc. · 1998
  • K972192Perception Inc. GPS-Xyz Diagnostic Ultrasound SystemPerception, Inc. · 1997
  • K972973Perception Inc. GPS-Tuv Diagnostic Ultrasound SystemPerception, Inc. · 1997

Recent decisions in IYO

The IYO category page

  • K262093Accuro XVRivanna Medical, Inc. · 2026
  • K260605Lilium one (USM330)Lilium Otsuka Co., Ltd. · 2026
  • K260313MD-6000S Bladder ScannerMEDA Co., Ltd. · 2026
  • K253452Accuro 3SRivanna Medical, Inc. · 2026
  • K260190ArthurROPCA ApS · 2026

https://510kreport.com/device/K974880 · printed Nov 4, 2026

Cite this page

510(k) Report. “K974880: Perception GPS-RST Diagnostic Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974880

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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