510(k) · Cleared

Cleared

Automatic Image Registration Software, Model Nsfu-050A

K992992510(k) TraditionalCleared Dec 3, 199987-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

Toshiba America Medical Systems, In.C · KPS System, Tomography, Computed, Emission

Cleared on Dec 3, 1999 as substantially equivalent to K931297 (Toshiba America Medical Systems, In.C, 1993) and 1 other predicate after an 87-day review. Its family tree reaches back 1 generation to 1993.

Decided: Dec 3, 1999
Review: 87 days
Class: Class II
Product code: KPS
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K931297 (1993). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK931297 GCA-7200AToshiba America Medical Systems, In.C · 1993 · Recalled
This deviceK992992 Automatic Image Registration Software, Model Nsfu-050AToshiba America Medical Systems, In.C · 1999

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K931297	GCA-7200A	Toshiba America Medical Systems, In.C	1993	1
0 (this device)	K992992	Automatic Image Registration Software, Model Nsfu-050A	Toshiba America Medical Systems, In.C	1999	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0

FIG. 1 — Lineage of K992992, 1993–1999Source: 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 18.7 · 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
*	K931297	GCA-7200A Summary page 1 …omography System Common Name: Gamma Camera Option [Fed. Reg. No. 892.1200, Pro. Code: 90 KPS] Predicate Devices: Toshiba GMS-5500A/UI Nuclear Medicine Image Processor (K931297) ADAC Image Fusion and Review System (K973233) Reason for Submission New option for existing product Description of this Device…	Toshiba America Medical Systems, In.C	1993	1
*	K973233	Image Fusion and Review System Summary page 1 …tion [Fed. Reg. No. 892.1200, Pro. Code: 90 KPS] Predicate Devices: Toshiba GMS-5500A/UI Nuclear Medicine Image Processor (K931297) ADAC Image Fusion and Review System (K973233) Reason for Submission New option for existing product Description of this Device: The Automatic Image Registration Software,…	Adac Laboratories	1997	—

Also cleared against K931297: 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?

1 of the 2 ancestors has a recall of any class.
1 other device also cites its predicate K931297.

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/K992992 · printed Nov 4, 2026

Cite this page

510(k) Report. “K992992: Automatic Image Registration Software, Model Nsfu-050A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992992

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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