510(k) · Cleared

Cleared

Code AC: Attenuation Correction System for Dual-Head Variable-Angle Gamma Camera with Coincidence Option (Code)

K994167510(k) TraditionalCleared Mar 7, 200089-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

Ge Medical Systems F.I. Haifa · KPS System, Tomography, Computed, Emission

Cleared on Mar 7, 2000 as substantially equivalent to K980959 (Ge Medical Systems F.I. Haifa, 1998) after an 89-day review. Its family tree reaches back 2 generations to 1995.

Decided: Mar 7, 2000
Review: 89 days
Class: Class II
Product code: KPS
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K952674 (1995). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK952674 Transact: Attenuation Correction System for the Apex Cardial Gamma…Elscint, Inc. · 1995 · Recalled
1 generation backK980959 Vtransact: Attenuation Correction System for Dual-Head Variable…Ge Medical Systems F.I. Haifa · 1998
This deviceK994167 Code AC: Attenuation Correction System for Dual-Head Variable-Angle…Ge Medical Systems F.I. Haifa · 2000

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K952674	Transact: Attenuation Correction System for the Apex Cardial Gamma Camera	Elscint, Inc.	1995	1
−1	K980959	Vtransact: Attenuation Correction System for Dual-Head Variable Angle Gamma…	Ge Medical Systems F.I. Haifa	1998	—
0 (this device)	K994167	Code AC: Attenuation Correction System for Dual-Head Variable-Angle Gamma…	Ge Medical Systems F.I. Haifa	2000	—

FIG. 1 — Lineage of K994167, 1995–2000Source: 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

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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
*	K980959	Vtransact: Attenuation Correction System for Dual-Head Variable Angle Gamma Camera Summary page 1 …sion Modification of legally marketed device. Identification of Legally Marketed Equivalent Devices VTransACT option for the Apex VariCam (Millenium VG Gamma Camera) - K980959 Device Description The CoDe AC attenuation correction system is an addition to the Apex VariCam and Millennium VG gamma cameras…	Ge Medical Systems F.I. Haifa	1998	—

Also cleared against K980959: 2 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?

The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 2.7 years on median.
1 of the 2 ancestors has a recall of any class.
2 other devices also cite its predicate K980959.

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 obtain attenuation corrected Positron Emission Tomography (PET) images, by a Gamma Camera.

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/K994167 · printed Nov 4, 2026

Cite this page

510(k) Report. “K994167: Code AC: Attenuation Correction System for Dual-Head Variable-Angle Gamma Camera with Coincidence Option (Code).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K994167

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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