510(k) · Cleared

Cleared

Cedars-Sinai BPGS and Moco

K010509510(k) TraditionalCleared Apr 27, 200165-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 Apr 27, 2001 after a 65-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 11 later devices descend from it.

Decided: Apr 27, 2001
Review: 65 days
Class: Class II
Product code: KPS
Recalls: None
Predicates: 0

11 later devices descend from it, 4 citing it directly.

This deviceK010509 Cedars-Sinai BPGS and MocoSmv America · 2001
Descendant · cites it directly · 9 of its ownK023110 Cedars-Sinai Motion Correction (Moco) Software, Model 111005Digirad Corp. · 2002
Descendant · cites it directly · 7 of its ownK052430 Cardius-1, Cardius-2, Cardius-3, 2020TC Spect Imaging SystemDigirad Corp. · 2005
Descendant · 2 generations on · 6 of its ownK070542 Cardius 1, 2 and 3 Xpo and 2020TC Spect Imaging SystemsDigirad Corp. · 2007
Descendant · 3 generations on · 2 of its ownK100838 Ergo Imaging SystemDigirad Corp. · 2010
Descendant · 2 generations on · 1 of its ownK082368 Cardius-1, -2, -3, and Cardius 1,2,3 Xpo Spect Imaging Systems…Digirad Corp. · 2008

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2002high 2 (2007) · low 0 (2003)2026

Most influential descendants

Showing 5 of 11 · See all

K023110Cedars-Sinai Motion Correction (Moco) Software, Model 111005Digirad Corp. · 2002 · cites it directly9descendants
K052430Cardius-1, Cardius-2, Cardius-3, 2020TC Spect Imaging SystemDigirad Corp. · 2005 · cites it directly7descendants
K070542Cardius 1, 2 and 3 Xpo and 2020TC Spect Imaging SystemsDigirad Corp. · 2007 · 2 generations on6descendants
K100838Ergo Imaging SystemDigirad Corp. · 2010 · 3 generations on2descendants
K082368Cardius-1, -2, -3, and Cardius 1,2,3 Xpo Spect Imaging Systems, 2020TC Spect Imaging…Digirad Corp. · 2008 · 2 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K010509	Cedars-Sinai BPGS and Moco	Smv America	2001	—
+1	K023110	Cedars-Sinai Motion Correction (Moco) Software, Model 111005	Digirad Corp.	2002	—
+1	K052430	Cardius-1, Cardius-2, Cardius-3, 2020TC Spect Imaging System	Digirad Corp.	2005	—
+2	K070542	Cardius 1, 2 and 3 Xpo and 2020TC Spect Imaging Systems	Digirad Corp.	2007	—
+3	K100838	Ergo Imaging System	Digirad Corp.	2010	—
+2	K082368	Cardius-1, -2, -3, and Cardius 1,2,3 Xpo Spect Imaging Systems, 2020TC Spect…	Digirad Corp.	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2005	1	0
2007	2	0
2008	2	0
2009	1	0
2010	1	0
2011	2	0
2013	1	0

FIG. 1 — Lineage of K010509, 2001–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (11)

See all 11

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

Number	Device	Applicant	Decided	Descendants
K023110	Cedars-Sinai Motion Correction (Moco) Software, Model 111005	Digirad Corp.	2002	9
K052430	Cardius-1, Cardius-2, Cardius-3, 2020TC Spect Imaging System	Digirad Corp.	2005	7
K100714	CSMC Cardiac Suite-Nuclear Medicine Software Applicaton Model 2010-01	Cedars-Sinai Medical Center	2011	0
K082904	Stasys Motion Correction Software	Digirad Corp.	2008	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?

Of its descendants, K023110 (Digirad Corp., 2002) has gone furthest, with 9 descendants of its own.

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	—

https://510kreport.com/device/K010509 · printed Nov 6, 2026

Cite this page

510(k) Report. “K010509: Cedars-Sinai BPGS and Moco.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010509

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026