510(k) · Cleared

Cleared

Perception Inc. GPS-Tuv Diagnostic Ultrasound System

K972973510(k) TraditionalCleared Oct 15, 199765-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 Oct 15, 1997 as substantially equivalent to K963616 (Aloka Co., Ltd., 1997) and 4 other predicates after a 65-day review. Its family tree reaches back 2 generations to 1992. 2 later devices descend from it.

Decided: Oct 15, 1997
Review: 65 days
Class: Class II
Product code: IYO
Recalls: None
Predicates: 5

Its longest line of descent runs back 2 generations to K921750 (1992). 6 ancestors in all. 2 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 2 generations backK921750 Cvis Insight Iii SystemCardiovascular Imaging Systems, Inc. · 1992
1 generation backK962662 Vingmed Sound Color Flow Mapping SystemDiasonics, Inc. · 1997
This deviceK972973 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 2 of 2 · See all

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
−2	K921750	Cvis Insight Iii System	Cardiovascular Imaging Systems, Inc.	1992	—
−1	K962662	Vingmed Sound Color Flow Mapping System	Diasonics, Inc.	1997	—
0 (this device)	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	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	1	0
1995	1	0
1996	1	0
1997	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	2	0

FIG. 1 — Lineage of K972973, 1992–1998Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K963616	Aloka SSD-1700 Diagnostic Ultrasound System Summary page 6 …Page 6 === COMPANY PERCEPTION INC. ALOKA CO. DIASONICS DIASONICS SHARPLAN SPECS ULTRASOUND ULTRASOUND Model ' GPS-TUV SSD-1700 SYNERGY CFM800/ECHOPAC \| U SIGHT 9010 K# - K 963616 K935024 K 924079 K 945796 K 962662 Transducer Type : Sector X X X Convex Array X X Frequencies: 3.0 X 2-12 3.5 X X 12.5 X Gray Sc…	Aloka Co., Ltd.	1997	—
*	K935024	ESI-5000 Summary page 6 …= COMPANY PERCEPTION INC. ALOKA CO. DIASONICS DIASONICS SHARPLAN SPECS ULTRASOUND ULTRASOUND Model ' GPS-TUV SSD-1700 SYNERGY CFM800/ECHOPAC \| U SIGHT 9010 K# - K 963616 K935024 K 924079 K 945796 K 962662 Transducer Type : Sector X X X Convex Array X X Frequencies: 3.0 X 2-12 3.5 X X 12.5 X Gray Scale Leve…	Elscint, Inc.	1996	—
*	K924079	CFM-800 Color Flow Mapping System Summary page 6 …Y PERCEPTION INC. ALOKA CO. DIASONICS DIASONICS SHARPLAN SPECS ULTRASOUND ULTRASOUND Model ' GPS-TUV SSD-1700 SYNERGY CFM800/ECHOPAC \| U SIGHT 9010 K# - K 963616 K935024 K 924079 K 945796 K 962662 Transducer Type : Sector X X X Convex Array X X Frequencies: 3.0 X 2-12 3.5 X X 12.5 X Gray Scale Levels 256 25…	Diasonics, Inc.	1993	—
*	K962662	Vingmed Sound Color Flow Mapping System Summary page 6 …ALOKA CO. DIASONICS DIASONICS SHARPLAN SPECS ULTRASOUND ULTRASOUND Model ' GPS-TUV SSD-1700 SYNERGY CFM800/ECHOPAC \| U SIGHT 9010 K# - K 963616 K935024 K 924079 K 945796 K 962662 Transducer Type : Sector X X X Convex Array X X Frequencies: 3.0 X 2-12 3.5 X X 12.5 X Gray Scale Levels 256 256 Pre-processing X…	Diasonics, Inc.	1997	—
*	K945796	Sharplan Usight 9010 Laparoscopic Ultrasound System Summary page 6 …ION INC. ALOKA CO. DIASONICS DIASONICS SHARPLAN SPECS ULTRASOUND ULTRASOUND Model ' GPS-TUV SSD-1700 SYNERGY CFM800/ECHOPAC \| U SIGHT 9010 K# - K 963616 K935024 K 924079 K 945796 K 962662 Transducer Type : Sector X X X Convex Array X X Frequencies: 3.0 X 2-12 3.5 X X 12.5 X Gray Scale Levels 256 256 Pre-pro…	Sharplan Lasers, Inc.	1995	—

Also cleared against K963616: 4 other devices →

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K981834	Perception Inc, GPS-6TBMD Diagnostic Ultrasound System	Perception, Inc.	1998	0
K974880	Perception GPS-RST Diagnostic Ultrasound System	Perception, Inc.	1998	0

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 5 years and passes through 3 companies; a new generation was cleared every 4.5 years on median.
None of the 6 ancestors has a recall.
Of its descendants, K981834 (Perception, Inc., 1998) has gone furthest, with 0 descendants of its own.
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

2007high 20 (2007) · low 5 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYO

171in 2025

2007high 220 (2024) · low 17 (2007)2026

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

Recalls per year · IYO

1in 2022

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

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

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?

Diagnostic ultrasound imaging 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.

https://510kreport.com/device/K972973 · printed Nov 4, 2026

Cite this page

510(k) Report. “K972973: Perception Inc. GPS-Tuv 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/K972973

Report an extraction error

Are you the manufacturer?

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