510(k) · Cleared

Cleared

Hamamatsu Pet Scanner, Model SHR-22000

K982171510(k) TraditionalCleared Sep 17, 199890-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

Hamamatsu Photonics K.K. · KPS System, Tomography, Computed, Emission

Cleared on Sep 17, 1998 as substantially equivalent to K962797 (Cti Pet Systems, Inc., 1996) after a 90-day review. Its family tree reaches back 1 generation to 1996.

Decided: Sep 17, 1998
Review: 90 days
Class: Class II
Product code: KPS
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K962797 (1996). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK962797 Ecat Exact & Ecat Exact HR+Cti Pet Systems, Inc. · 1996 · Recalled
This deviceK982171 Hamamatsu Pet Scanner, Model SHR-22000Hamamatsu Photonics K.K. · 1998

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K962797	Ecat Exact & Ecat Exact HR+	Cti Pet Systems, Inc.	1996	14
0 (this device)	K982171	Hamamatsu Pet Scanner, Model SHR-22000	Hamamatsu Photonics K.K.	1998	—

FIG. 1 — Lineage of K982171, 1996–1998Source: 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? (1)

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
*	K962797	Ecat Exact & Ecat Exact HR+ Summary page 1 …ared: May 18, 1998 A. LEGALLY MARKETED PREDICATE DEVICES The Hamamatsu PET Scanner Model SHR-22000 is substantially equivalent to the Siemens ECAT Exact HR PET scanner (K962797). B. DEVICE DESCRIPTION The Hamamatsu PET Scanner Model SHR-22000 is similar to previous PET scanners marketed by other compani…	Cti Pet Systems, Inc.	1996	14

Also cleared against K962797: 4 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?

Its one ancestor has a recall.
4 other devices also cite its predicate K962797.

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?

The Hamamatsu PET Scanner Model SHR-22000 is indicated for the imaging of the distribution

of physiological tracer molecules labeled with positron-emitting isotopes. Such images are

particularly useful in the assessment of brain function.

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/K982171 · printed Nov 5, 2026

Cite this page

510(k) Report. “K982171: Hamamatsu Pet Scanner, Model SHR-22000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K982171

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