510(k) Report

510(k) · Cleared

Cleared

Perception Inc. GPS-Xyz Diagnostic Ultrasound System

K972192510(k) TraditionalCleared Dec 17, 1997190-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 Dec 17, 1997 as substantially equivalent to K925486 (Aloka Co., Ltd., 1993) and 4 other predicates after a 190-day review. Its family tree reaches back 1 generation to 1991. 1 later device descends from it.

Decided
Dec 17, 1997
Review
190 days
Class
Class II
Product code
IYO
Recalls
None
Predicates
5

Its longest line of descent runs back 1 generation to K905198 (1991). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1995: 1 other ancestor1993: 1 other ancestor1992: 2 other ancestors1998: 1 descendant clearedK905198 · Diagnostic Ultrasound System Type 3535 · Bruel & Kjaer · 19911990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors 1 generation forward: 1 descendant K905198 · Diagnostic Ultrasound System Type 3535 · Bruel & Kjaer · 19910
  1. Root · 1 generation backK905198 Diagnostic Ultrasound System Type 3535Bruel & Kjaer · 1991
  2. This deviceK972192 Perception Inc. GPS-Xyz Diagnostic Ultrasound SystemPerception, Inc. · 1997
  3. Descendant · cites it directly · 0 of its ownK981834 Perception Inc, GPS-6TBMD Diagnostic Ultrasound SystemPerception, Inc. · 1998

Most influential descendants

Showing 1 of 1 · See all
  • K981834Perception Inc, GPS-6TBMD Diagnostic Ultrasound SystemPerception, Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K905198Diagnostic Ultrasound System Type 3535Bruel & Kjaer1991—
0 (this device)K972192Perception Inc. GPS-Xyz Diagnostic Ultrasound SystemPerception, Inc.1997—
+1K981834Perception Inc, GPS-6TBMD Diagnostic Ultrasound SystemPerception, Inc.1998—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199220
199310
199510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
FIG. 1 — Lineage of K972192, 1991–1998Source: 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
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What was it cleared against? (6)

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
*K925486Ust-5522-7.5 & Ust-5522L-7.5 Intraoperative Trans.
Summary page 1
…Summary Prepared: June 9, 1997 Perception Inc. GPS-XYZ Diagnostic Ultrasound System 3. Predi Device Inf I 1) Aloka Model SSD650CL Ultrasound Systems and Transducers, K# 925486/920374. 2) Bruel and Kjaer Diagnostic Ultrasound Type 3535 System and Transducers 8549, 8434, 8536, 8537, 8551 and 8550, K#90519…
Aloka Co., Ltd.1993—
*K920374Aloka 650CL Diagnostic Ultrasound System
Summary page 1
…Prepared: June 9, 1997 Perception Inc. GPS-XYZ Diagnostic Ultrasound System 3. Predi Device Inf I 1) Aloka Model SSD650CL Ultrasound Systems and Transducers, K# 925486/920374. 2) Bruel and Kjaer Diagnostic Ultrasound Type 3535 System and Transducers 8549, 8434, 8536, 8537, 8551 and 8550, K#905198/91492…
Ge Medical Systems Information Technologies1992—
*K905198Diagnostic Ultrasound System Type 3535
Summary page 1
…Ultrasound Systems and Transducers, K# 925486/920374. 2) Bruel and Kjaer Diagnostic Ultrasound Type 3535 System and Transducers 8549, 8434, 8536, 8537, 8551 and 8550, K#905198/914925. 3) Sharplan, USight 9010, K#945796. 4) International Ultrasound Systems Inc., Model AU-530, Pre-amendment Device. 4.…
Bruel & Kjaer1991—
*K914945Diagnostic Ultrasound System Type 3535, Modified
Our OCR of the scanned summary read K914925, FDA’s number for Medac System/3 (Davicon, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Bruel and Kjaer Diagnostic Ultrasound Type 3535 System and Transducers”.
Bruel & Kjaer Industri A/S1992—
*K945796Sharplan Usight 9010 Laparoscopic Ultrasound System
Summary page 1
…/920374. 2) Bruel and Kjaer Diagnostic Ultrasound Type 3535 System and Transducers 8549, 8434, 8536, 8537, 8551 and 8550, K#905198/914925. 3) Sharplan, USight 9010, K#945796. 4) International Ultrasound Systems Inc., Model AU-530, Pre-amendment Device. 4. Device D - General Description The GPS-XYZ D…
Sharplan Lasers, Inc.1995—
*—International Ultrasound Systems Inc., Model AU-530
Named without a submission number
—

Also cleared against K925486: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K981834Perception Inc, GPS-6TBMD Diagnostic Ultrasound SystemPerception, Inc.19980

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?

  • None of the 5 ancestors has a recall.
  • Of its descendants, K981834 (Perception, Inc., 1998) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K925486.

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?

The GPS-XYZ device is a diagnostic ultrasound system which produces two-dimensional diagnostic ultrasonic images. The following intended uses are identified for the transducer applications: General Radiology, Abdominal, Cardiac and Vascular, with the use of ultrasonic probes from 2.8-12.5 MHz. There is no transcranial application for this device.

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 K925486

1 other device cites the same predicate.

  • K953759Diagnostic Ultrasound TransducerBiosound, Inc. · 1996

More from Perception, Inc.

4 FDA decisions under this applicant name. See the company

  • K981834Perception Inc, GPS-6TBMD Diagnostic Ultrasound SystemPerception, Inc. · 1998
  • K974880Perception GPS-RST Diagnostic Ultrasound SystemPerception, Inc. · 1998
  • K972973Perception Inc. GPS-Tuv Diagnostic Ultrasound SystemPerception, Inc. · 1997

Recent decisions in IYO

The IYO category page

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  • K253452Accuro 3SRivanna Medical, Inc. · 2026
  • K260190ArthurROPCA ApS · 2026

https://510kreport.com/device/K972192 · printed Nov 4, 2026

Cite this page

510(k) Report. “K972192: Perception Inc. GPS-Xyz 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/K972192

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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