510(k) · Cleared

Cleared

Clearvision Nuclear Medicine Imaging System

K072191510(k) TraditionalCleared Oct 25, 200780-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

Gvi Technology Partners · KPS System, Tomography, Computed, Emission

Cleared on Oct 25, 2007 as substantially equivalent to K070542 (Digirad Corp., 2007) and 1 other predicate after an 80-day review. Its family tree reaches back 5 generations to 1989.

Decided: Oct 25, 2007
Review: 80 days
Class: Class II
Product code: KPS
Recalls: None
Predicates: 2

Its longest line of descent runs back 5 generations to K885054 (1989). 15 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 5 generations backK885054 System Seventy SevenScinticor, Inc. · 1989
4 generations backK982855 Digirad 2020TC Spect Imaging SystemDigirad Corp. · 1998
3 generations backK051549 Cardius-1, Cardius-2, Cardius-3, 2020TC Spect Imaging SystemDigirad Corp. · 2005
2 generations backK052430 Cardius-1, Cardius-2, Cardius-3, 2020TC Spect Imaging SystemDigirad Corp. · 2005
1 generation backK070542 Cardius 1, 2 and 3 Xpo and 2020TC Spect Imaging SystemsDigirad Corp. · 2007
This deviceK072191 Clearvision Nuclear Medicine Imaging SystemGvi Technology Partners · 2007

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K885054	System Seventy Seven	Scinticor, Inc.	1989	—
−4	K982855	Digirad 2020TC Spect Imaging System	Digirad Corp.	1998	—
−3	K051549	Cardius-1, Cardius-2, Cardius-3, 2020TC Spect Imaging System	Digirad Corp.	2005	—
−2	K052430	Cardius-1, Cardius-2, Cardius-3, 2020TC Spect Imaging System	Digirad Corp.	2005	—
−1	K070542	Cardius 1, 2 and 3 Xpo and 2020TC Spect Imaging Systems	Digirad Corp.	2007	—
0 (this device)	K072191	Clearvision Nuclear Medicine Imaging System	Gvi Technology Partners	2007	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	2	0
1993	1	0
1995	1	0
1997	1	0
2000	1	0
2001	1	0
2002	1	0
2003	2	0

FIG. 1 — Lineage of K072191, 1989–2007Source: 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

Get a 510(k) Report

What was it cleared against? (2)

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
*	K070542	Cardius 1, 2 and 3 Xpo and 2020TC Spect Imaging Systems Summary page 1 …Cardius 1 XPO and Cardius 2 XPO SPECT Imaging Systems 510(k) Number: K070542 CDRH Product Code: 90 KPS GVI Medical Devices…	Digirad Corp.	2007	—
*	K023373	Onepass Nuclear Imaging System, Model 70-500101 Summary page 2 …out and electronics are identical in both physical and performance characteristics to the detector used on the GVI Medical Devices OnePass Nuclear Imaging System (510(k) K023373). The primary difference between the ClearVision and the Cardius 1 and 2 XPO Systems is in detector technology and collimation. C…	Gvi Technology Partners	2003	1

Also cleared against K070542: 3 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 18 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
2 of the 15 ancestors have a recall of any class.
3 other devices also cite its predicate K070542.

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. 2007, this device’s year, is highlighted.

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?

The ClearVision nuclear medicine imaging system is intended for use as a diagnostic imaging device to acquire and process gated and non-gated Single Photon Emission Computed Tomography (SPECT) images.

Used with appropriate radiopharmaceuticals, the ClearVision system produces images that depict the anatomical distribution of radioisotopes within the myocardium.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K072191 · printed Nov 6, 2026

Cite this page

510(k) Report. “K072191: Clearvision Nuclear Medicine Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072191

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