510(k) · Cleared

Cleared

Vcar Option to the DST and DST-XL Gamma Cameras and Vision Powerstation Computer

K972686510(k) TraditionalCleared Oct 14, 199789-day reviewClass II21 CFR 892.1200

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

Smv America · KPS System, Tomography, Computed, Emission

Cleared on Oct 14, 1997 as substantially equivalent to K963273 (Smv America, 1997) and 2 other predicates after an 89-day review. Its family tree reaches back 2 generations to 1993.

Decided: Oct 14, 1997
Review: 89 days
Class: Class II
Product code: KPS
Recalls: None
Predicates: 3

Its longest line of descent runs back 2 generations to K930428 (1993). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK930428 Penn-Pet ScannerUgm Medical Systems, Inc. · 1993
1 generation backK963273 Vcar Option to Vision FX-80 Gamma Camera and Power StationSmv America · 1997
This deviceK972686 Vcar Option to the DST and DST-XL Gamma Cameras and Vision…Smv America · 1997

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K930428	Penn-Pet Scanner	Ugm Medical Systems, Inc.	1993	—
−1	K963273	Vcar Option to Vision FX-80 Gamma Camera and Power Station	Smv America	1997	—
0 (this device)	K972686	Vcar Option to the DST and DST-XL Gamma Cameras and Vision Powerstation Computer	Smv America	1997	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0

FIG. 1 — Lineage of K972686, 1993–1997Source: 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 KPS? 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 KPS device

#1 K253564 uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI…score 18.6 · 17 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (3)

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
*	K963273	Vcar Option to Vision FX-80 Gamma Camera and Power Station Summary page 1 …VCAR option to DST-XL Gamma Camera and VISION Powerstation Predicate Devices: SPONSOR PRODUCT Preamendment Status or 510(k) Number SMV America. VCAR option to FX-80&PS K963273 UGM Medical Systems, Inc. \| Penn-PET K930428 (marketed as GE Quest 300) ADAC Laboratories MCD option to VERTEX Epic K952684 Syste…	Smv America	1997	—
*	K930428	Penn-Pet Scanner Summary page 1 …Powerstation Predicate Devices: SPONSOR PRODUCT Preamendment Status or 510(k) Number SMV America. VCAR option to FX-80&PS K963273 UGM Medical Systems, Inc. \| Penn-PET K930428 (marketed as GE Quest 300) ADAC Laboratories MCD option to VERTEX Epic K952684 System Wi SMV America Appendices…	Ugm Medical Systems, Inc.	1993	—
*	K952684	Vertex Epic MCD Summary page 1 …) Number SMV America. VCAR option to FX-80&PS K963273 UGM Medical Systems, Inc. \| Penn-PET K930428 (marketed as GE Quest 300) ADAC Laboratories MCD option to VERTEX Epic K952684 System Wi SMV America Appendices DS-VCAR Option 510(k) Page 46 of 48 Device Description Summary: The VCAR optio…	Adac Laboratories	1995	2

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 4 years and passes through 2 companies; a new generation was cleared every 3.8 years on median.
1 of the 3 ancestors has a recall of any class.

How does its category compare?

All KPS devices

KPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KPS

12in 2025

2007high 17 (2008) · low 3 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KPS

65in 2025

2007high 112 (2015) · low 25 (2008)2026

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

Recalls per year · KPS

16in 2025

2007high 34 (2011) · low 4 (2010)2026

Class I (17 since 2007) Class II/III not classified

Adverse event reports per year · KPS

36in 2025

2007high 240 (2013) · low 10 (2016)2025

MAUDE reports naming product code KPS, 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	8	38	22	38
2008	17	25	16	11
2009	9	42	14	15
2010	3	91	4	44
2011	7	28	34	56
2012	6	94	13	34
2013	11	84	13	240
2014	11	92	18	33
2015	3	112	5	24
2016	11	65	16	10
2017	11	104	11	31
2018	13	59	12 (3)	26
2019	3	60	5 (5)	105
2020	12	72	8	22
2021	15	66	4	10
2022	5	60	8 (6)	15
2023	12	63	6 (3)	22
2024	11	59	15	23
2025	12	65	16	36
2026	6	67	6	—

What is it indicated for?

To detect or image the distribution of radionuclides in the body or organ, using the following technique(s).

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/K972686 · printed Nov 5, 2026

Cite this page

510(k) Report. “K972686: Vcar Option to the DST and DST-XL Gamma Cameras and Vision Powerstation Computer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K972686

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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