510(k) · Cleared

Cleared

Stasys Motion Correction Software

K082904510(k) TraditionalCleared Dec 17, 200878-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

Digirad Corp. · KPS System, Tomography, Computed, Emission

Cleared on Dec 17, 2008 as substantially equivalent to K023110 (Digirad Corp., 2002) and 1 other predicate after a 78-day review. Its family tree reaches back 2 generations to 2000.

Decided: Dec 17, 2008
Review: 78 days
Class: Class II
Product code: KPS
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K003264 (2000). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK003264 QPS/BPGS/Moco Processing Applications for Entegra WorkstationGe Medical Systems F.I. Haifa · 2000
1 generation backK023110 Cedars-Sinai Motion Correction (Moco) Software, Model 111005Digirad Corp. · 2002
This deviceK082904 Stasys Motion Correction SoftwareDigirad Corp. · 2008

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K003264	QPS/BPGS/Moco Processing Applications for Entegra Workstation	Ge Medical Systems F.I. Haifa	2000	—
−1	K023110	Cedars-Sinai Motion Correction (Moco) Software, Model 111005	Digirad Corp.	2002	—
0 (this device)	K082904	Stasys Motion Correction Software	Digirad Corp.	2008	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0

FIG. 1 — Lineage of K082904, 2000–2008Source: 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? (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
*	K023110	Cedars-Sinai Motion Correction (Moco) Software, Model 111005 Summary page 1 …Correction Software is substantially equivalent to the following cleared devices: (1) Cedars-Sinai Motion Correction (MoCo) Software cleared November 22, 2002 under K023 110 for Digirad Corporation. (2) Cedars-Sinai BPGS and MoCo software cleared April 27, 2001 under K010509 for GE/SMV America. E.…	Digirad Corp.	2002	—
*	K010509	Cedars-Sinai BPGS and Moco Summary page 1 …ion Correction (MoCo) Software cleared November 22, 2002 under K023 110 for Digirad Corporation. (2) Cedars-Sinai BPGS and MoCo software cleared April 27, 2001 under K010509 for GE/SMV America. E. Device Description STASYS~m is a software application developed by Digirad for the correction of SPEC…	Smv America	2001	—

Also cleared against K023110: 1 other device →

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 8 years and passes through 2 companies; a new generation was cleared every 6.1 years on median.
None of the 3 ancestors has a recall.
1 other device also cites its predicate K023110.

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. 2008, 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 STASYS Motion Correction software program is intended for use in correcting patient motion artifacts in SPECT data acquired on a nuclear medicine gamma camera system.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K082904 · printed Nov 6, 2026

Cite this page

510(k) Report. “K082904: Stasys Motion Correction Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082904

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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