510(k) · Cleared

Recalled · Class I · 2019

Forte Gamma Camera System

K033254510(k) TraditionalCleared Oct 22, 200314-day reviewClass II21 CFR 892.1200Recalls 4 (3 Class I)

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Adac Laboratories · KPS System, Tomography, Computed, Emission

Cleared on Oct 22, 2003 as substantially equivalent to K982911 (Adac Laboratories, 1998) after a 14-day review. Its family tree reaches back 1 generation to 1998. 4 of the 5 devices in its family, counting itself, have a Class I recall. 3 later devices descend from it. It has been recalled 4 times, including 3 Class I recalls.

Decided: Oct 22, 2003
Review: 14 days
Class: Class II
Product code: KPS
Recalls: 4 (3 Class I)
Predicates: 1

Its longest line of descent runs back 1 generation to K982911 (1998). 3 later devices descend from it, 1 citing it directly. 4 of the 5 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 1 generation backK982911 FORTEAdac Laboratories · 1998 · Recalled (Class I)
This deviceK033254 Forte Gamma Camera SystemAdac Laboratories · 2003
Descendant · cites it directly · 2 of its ownK062298 Apollo Gamma Camera SystemAdac Laboratories · 2006 · Recalled (Class I)
Descendant · 2 generations on · 1 of its ownK080927 Brightview VCT Imaging SystemPhilips Medical Systems (Cleveland), Inc. · 2008 · Recalled (Class I)
Descendant · 3 generations on · 0 of its ownK083649 Cardius 3 X-ActDigirad Corp. · 2009

Class I recalls in this family

K982911 FORTEdirect predicate · 1998
K062298 Apollo Gamma Camera Systemcites it directly · 2006
K080927 Brightview VCT Imaging System2 generations on · 2008

Most influential descendants

Showing 3 of 3 · See all

K062298Apollo Gamma Camera SystemAdac Laboratories · 2006 · cites it directly2descendants
K080927Brightview VCT Imaging SystemPhilips Medical Systems (Cleveland), Inc. · 2008 · 2 generations on1descendant
K083649Cardius 3 X-ActDigirad Corp. · 2009 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K982911	FORTE	Adac Laboratories	1998	Class I
0 (this device)	K033254	Forte Gamma Camera System	Adac Laboratories	2003	—
+1	K062298	Apollo Gamma Camera System	Adac Laboratories	2006	Class I
+2	K080927	Brightview VCT Imaging System	Philips Medical Systems (Cleveland), Inc.	2008	Class I
+3	K083649	Cardius 3 X-Act	Digirad Corp.	2009	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	1
2008	1	1
2009	1	0

FIG. 1 — Lineage of K033254, 1998–2009Source: 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.

4 devices in this family have a Class I recall. 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

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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
*	K982911	FORTE Summary page 1 …90 KPS C. Date prepared: September 18,2003 D. Predicate Device: ForteTMGamma Camera System (K982911) E. Intended Use: The Forte Gamma Camera System is intended to produce images depicting the anatomical distributions of s…	Adac Laboratories	1998	Class I

Also cleared against K982911: 1 other device →

What descends from it? (3)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K062298	Apollo Gamma Camera System Class I	Adac Laboratories	2006	2

Has anything in its family been recalled? (4 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Sep 19, 2019	Class I	Z-0214-2020	Nonconforming Material/Component	An issue with the Detector for the Forte Family of cameras may result in either detector 1 or detector 2 falling unimpeded vertically to the end stops of its travel limit.
Sep 19, 2019	Class I	Z-0217-2020	Nonconforming Material/Component	An issue with the Detector for the Forte Family of cameras may result in either detector 1 or detector 2 falling unimpeded vertically to the end stops of its travel limit.
Sep 19, 2019	Class I	Z-0215-2020	Nonconforming Material/Component	An issue with the Detector for the Forte Family of cameras may result in either detector 1 or detector 2 falling unimpeded vertically to the end stops of its travel limit.
Mar 6, 2015	Class II	Z-1777-2015	Nonconforming Material/Component	The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K982911FORTEAdac Laboratories · 1998 · Direct predicate · ◆ on the line of descent in FIG. 12 Class I recalls
K062298Apollo Gamma Camera SystemAdac Laboratories · 2006 · Cites it directly · ◆ in the 2006 descendants bar of FIG. 11 Class I recall
K080927Brightview VCT Imaging SystemPhilips Medical Systems (Cleveland), Inc. · 2008 · 2 generations on · ◆ in the 2008 descendants bar of FIG. 12 Class I recalls

What does this lineage say?

Its one ancestor has a recall, Class I.
Of its descendants, K062298 (Adac Laboratories, 2006) has gone furthest, with 2 descendants of its own.
1 other device also cites its predicate K982911.

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 ForteTMGamma Camera System is intended to produce images depicting the

anatomical distributions of single photon and positron emitting radioisotopes within the

human body for interpretation by medical personnel.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K033254 · printed Nov 3, 2026

Cite this page

510(k) Report. “K033254: Forte Gamma Camera System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033254

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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