510(k) Report

510(k) · Cleared

Cleared

Perception Inc, GPS-6TBMD Diagnostic Ultrasound System

K981834510(k) TraditionalCleared Sep 29, 1998126-day reviewClass II21 CFR 892.1550

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

Perception, Inc. · IYN System, Imaging, Pulsed Doppler, Ultrasonic

Cleared on Sep 29, 1998 as substantially equivalent to K963616 (Aloka Co., Ltd., 1997) and 7 other predicates after a 126-day review. Its family tree reaches back 3 generations to 1992.

Decided
Sep 29, 1998
Review
126 days
Class
Class II
Product code
IYN
Recalls
None
Predicates
8

Its longest line of descent runs back 3 generations to K921750 (1992). 14 ancestors in all, the oldest K900469 (1990). No later device cites it as a predicate yet.

Other ancestors, by year cleared 1997: 3 other ancestors1996: 1 other ancestor1993: 2 other ancestors1990: 1 other ancestor1995: 1 other ancestor1992: 2 other ancestors1991: 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: 6 other ancestors2 generations back: 5 other ancestors 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 deviceK981834 Perception Inc, GPS-6TBMD 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)K981834Perception Inc, GPS-6TBMD Diagnostic Ultrasound SystemPerception, Inc.1998—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199110
199220
199320
199510
199610
199730
FIG. 1 — Lineage of K981834, 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 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. #1 K240850 EPIQ Series Diagnostic Ultrasound Systems…score 32.1 · 24 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? (8)

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
Our OCR of the scanned summary read K063616, FDA’s number for Trident II Acetabular System (Howmedica Osteonics Corp.), decided Dec 20, 2006, after this device. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Aloka Co. Model SSD-1700”.
Aloka Co., Ltd.1997—
*K935024ESI-5000
Summary page 1
…evice : Perception Inc. GPS-6TBMD Diagnostic Ultrasound System 3. Predicate Device Information : 1. Aloka Co. Model SSD-1700 KO63616 2. Diasonics Ultrasound Synergy K935024 Models { CFM800 K924079 EchoPac K962662 3. Perception Inc. Model GPS-TUV K#972973. Model GPS-XYZ K#972192 4. Pie Medical Model…
Elscint, Inc.1996—
*K924079CFM-800 Color Flow Mapping System
Summary page 1
…GPS-6TBMD Diagnostic Ultrasound System 3. Predicate Device Information : 1. Aloka Co. Model SSD-1700 KO63616 2. Diasonics Ultrasound Synergy K935024 Models { CFM800 K924079 EchoPac K962662 3. Perception Inc. Model GPS-TUV K#972973. Model GPS-XYZ K#972192 4. Pie Medical Model Ultrasound Scanner #1150…
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 KO63616 2. Diasonics Ultrasound Synergy K935024 Models { CFM800 K924079 EchoPac K962662 3. Perception Inc. Model GPS-TUV K#972973. Model GPS-XYZ K#972192 4. Pie Medical Model Ultrasound Scanner #1150 Ki#900469 5. I…
Diasonics, Inc.1997—
*K972973Perception Inc. GPS-Tuv Diagnostic Ultrasound System
Summary page 1
…Information : 1. Aloka Co. Model SSD-1700 KO63616 2. Diasonics Ultrasound Synergy K935024 Models { CFM800 K924079 EchoPac K962662 3. Perception Inc. Model GPS-TUV K#972973. Model GPS-XYZ K#972192 4. Pie Medical Model Ultrasound Scanner #1150 Ki#900469 5. International Ultrasound Co. Model HR! 2000…
Perception, Inc.1997—
*K972192Perception Inc. GPS-Xyz Diagnostic Ultrasound System
Summary page 1
…Co. Model SSD-1700 KO63616 2. Diasonics Ultrasound Synergy K935024 Models { CFM800 K924079 EchoPac K962662 3. Perception Inc. Model GPS-TUV K#972973. Model GPS-XYZ K#972192 4. Pie Medical Model Ultrasound Scanner #1150 Ki#900469 5. International Ultrasound Co. Model HR! 2000 K#961229…
Perception, Inc.1997—
*K900469Ultrasound Scanner Model #1150
Summary page 1
…ergy K935024 Models { CFM800 K924079 EchoPac K962662 3. Perception Inc. Model GPS-TUV K#972973. Model GPS-XYZ K#972192 4. Pie Medical Model Ultrasound Scanner #1150 Ki#900469 5. International Ultrasound Co. Model HR! 2000 K#961229 EXHIBIT #B 8 Pages 4. Device Description : General Des…
Pie Medical USA BV1990—
*K961229HR12000 Ultrasound System
Summary page 1
…erception Inc. Model GPS-TUV K#972973. Model GPS-XYZ K#972192 4. Pie Medical Model Ultrasound Scanner #1150 Ki#900469 5. International Ultrasound Co. Model HR! 2000 K#961229 EXHIBIT #B 8 Pages 4. Device Description : General Description The Perception’s GPS-6TBMD Ultrasound System is…
International Ultrasound Corp.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 11 months on median.
  • None of the 14 ancestors has a recall.
  • 4 other devices also cite its predicate K963616.

How does its category compare?

All IYN devices

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

FDA decisions per year · IYN

57in 2025

2007: 132008: 252009: 182010: 292011: 392012: 432013: 512014: 562015: 542016: 602017: 642018: 592019: 472020: 572021: 462022: 532023: 442024: 502025: 572026 (partial year): 44
2007high 64 (2017) · low 13 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYN

124in 2025

2007: 26 days median2008: 18 days median2009: 29 days median2010: 67 days median2011: 46 days median2012: 37 days median2013: 60 days median2014: 39 days median2015: 55 days median2016: 56 days median2017: 83 days median2018: 85 days median2019: 79 days median2020: 72 days median2021: 105 days median2022: 105 days median2023: 115 days median2024: 119 days median2025: 124 days median2026 (partial year): 107 days median
2007high 124 (2025) · low 18 (2008)2026

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

Recalls per year · IYN

10in 2025

2007: 162008: 122009: 82010: 102011: 82012: 32013: 82014: 22015: 32016: 22018: 72020: 42021: 82022: 102023: 42024: 12025: 102026 (partial year): 2, 1 Class I
2007high 16 (2007) · low 0 (2017)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · IYN

610in 2025

2007: 32008: 22009: 92010: 172011: 182012: 202013: 182014: 482015: 1162016: 1452017: 1462018: 852019: 592020: 672021: 2132022: 1862023: 2292024: 2662025: 610
2007high 610 (2025) · low 2 (2008)2025

MAUDE reports naming product code IYN, 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
20071326163
20082518122
2009182989
201029671017
20113946818
20124337320
20135160818
20145639248
201554553116
201660562145
201764830146
20185985785
20194779059
20205772467
2021461058213
20225310510186
2023441154229
2024501191266
20255712410610
2026441072 (1)—

What is it indicated for?

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

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
  • K974880Perception GPS-RST 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

  • K974880Perception GPS-RST 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 IYN

The IYN category page

  • K261585Diagnostic Ultrasound System (Nuewa A20W); Diagnostic Ultrasound System (Nuewa A20); Diagnostic Ultrasound…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2026
  • K263150V10 Diagnostic Ultrasound System; cV10 Diagnostic Ultrasound System; H10 Diagnostic Ultrasound System; XV10…Samsung Medison Co., Ltd. · 2026
  • K261617Diagnostic Ultrasound System (Resona I10W);Diagnostic Ultrasound System (Resona I10 Exp);Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2026
  • K261933Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary care Diagnostics, LLC · 2026
  • K262548EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC · 2026

https://510kreport.com/device/K981834 · printed Nov 4, 2026

Cite this page

510(k) Report. “K981834: Perception Inc, GPS-6TBMD 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/K981834

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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