510(k) · Cleared

Recalled · Class II · 2018

Ventri 1.1

K080124510(k) TraditionalCleared Jan 31, 200814-day reviewClass II21 CFR 892.1200Recalls 2

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 Jan 31, 2008 as substantially equivalent to K051855 (Ge Medical Systems F.I. Haifa, 2005) and 2 other predicates after a 14-day review. Its family tree reaches back 5 generations to 1995. 5 of the 33 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it. It has been recalled 2 times.

Decided: Jan 31, 2008
Review: 14 days
Class: Class II
Product code: KPS
Recalls: 2
Predicates: 3

Its longest line of descent runs back 5 generations to K952674 (1995). 30 ancestors in all, the oldest K885054 (1989). 2 later devices descend from it, 2 citing it directly. 5 of the 33 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 5 generations backK952674 Transact: Attenuation Correction System for the Apex Cardial Gamma…Elscint, Inc. · 1995 · Recalled
4 generations backK980959 Vtransact: Attenuation Correction System for Dual-Head Variable…Ge Medical Systems F.I. Haifa · 1998
3 generations backK991841 Hawkeye Option for Dual-Head Variable Angle Gamma CameraGe Medical Systems F.I. Haifa · 1999 · Recalled (Class I)
2 generations backK022960 GE Quasar Nuclear Medicine SystemGe Medical Systems F.I. Haifa · 2002 · Recalled (Class I)
1 generation backK051855 VentriGe Medical Systems F.I. Haifa · 2005 · Recalled
This deviceK080124 Ventri 1.1Ge Medical Systems F.I. Haifa · 2008
Descendant · cites it directly · 0 of its ownK212004 MyoSPECT, MyoSpect ESGE Healthcare · 2021 · Recalled
Descendant · cites it directly · 0 of its ownK083504 GE Discovery NM/CT 570CGe Medical Systems F.I. Haifa · 2008 · Recalled

Class I recalls in this family

K914807 Apex Helix - adirect predicate · 1992
K022960 GE Quasar Nuclear Medicine System2 generations back · 2002
K962738 Millennium MT and Millennium MG Nuclear Medicine…2 generations back · 1996
K991841 Hawkeye Option for Dual-Head Variable Angle…3 generations back · 1999

Most influential descendants

Showing 2 of 2 · See all

K212004MyoSPECT, MyoSpect ESGE Healthcare · 2021 · cites it directly0descendants
K083504GE Discovery NM/CT 570CGe Medical Systems F.I. Haifa · 2008 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K952674	Transact: Attenuation Correction System for the Apex Cardial Gamma Camera	Elscint, Inc.	1995	1
−4	K980959	Vtransact: Attenuation Correction System for Dual-Head Variable Angle Gamma…	Ge Medical Systems F.I. Haifa	1998	—
−3	K991841	Hawkeye Option for Dual-Head Variable Angle Gamma Camera	Ge Medical Systems F.I. Haifa	1999	Class I
−2	K022960	GE Quasar Nuclear Medicine System	Ge Medical Systems F.I. Haifa	2002	Class I
−1	K051855	Ventri	Ge Medical Systems F.I. Haifa	2005	3
0 (this device)	K080124	Ventri 1.1	Ge Medical Systems F.I. Haifa	2008	—
+1	K212004	MyoSPECT, MyoSpect ES	GE Healthcare	2021	1
+1	K083504	GE Discovery NM/CT 570C	Ge Medical Systems F.I. Haifa	2008	1

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1989	1	0
1991	2	0
1992	4	1
1994	1	0
1995	3	1
1996	1	1
1997	2	0
1998	1	0
2000	1	0
2001	2	0
2002	1	0
2003	2	0
2004	1	0
2006	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2021	1	0

FIG. 1 — Lineage of K080124, 1995–2021Source: 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.

5 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

Get a 510(k) Report

What was it cleared against? (3)

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
*	K051855	Ventri Summary page 1 …Modification of legally marketed devices. Identification of Legally Marketed Equivalent Devices Ventri K051855 D-SPECTTm Cardiac Scanner System K062450 APEX Helix- A K914807…	Ge Medical Systems F.I. Haifa	2005	3
*	K062450	D-Spect Cardiac Scanner System Summary page 1 …entification of Legally Marketed Equivalent Devices Ventri K051855 D-SPECTTm Cardiac Scanner System K062450 APEX Helix- A K914807…	Spectrum Dynamics, Ltd.	2006	—
*	K914807	Apex Helix - a Summary page 1 …ri K051855 D-SPECTTm Cardiac Scanner System K062450 APEX Helix- A K914807 Page 55 of 60 S GE Medical System, F.L…	Elscint, Inc.	1992	Class I

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K212004	MyoSPECT, MyoSpect ES	GE Healthcare	2021	0
K083504	GE Discovery NM/CT 570C	Ge Medical Systems F.I. Haifa	2008	0

Has anything in its family been recalled? (5 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Nov 30, 2018	Class II	Z-2259-2020	Other	GE Healthcare has identified that a small number of Nuclear Medicine systems are operating without currently updated software. In a recent event, a patient s finger was injured during the Unload process while the automatic Unload feature…
Jan 9, 2013	Class II	Z-1168-2013	Device Design	GE Healthcare has recently become aware of an incident which caused a patient injury during an unload following an exam on a Ventri scanner. During a patient unload following a scan, the patients fingers may be pinched between the moving…

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.

K914807Apex Helix - aElscint, Inc. · 1992 · Direct predicate · ◆ in the 1992 ancestors bar of FIG. 11 Class I recall
K022960GE Quasar Nuclear Medicine SystemGe Medical Systems F.I. Haifa · 2002 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
K962738Millennium MT and Millennium MG Nuclear Medicine SystemsGE Medical Systems · 1996 · 2 generations back · ◆ in the 1996 ancestors bar of FIG. 13 Class I recalls
K991841Hawkeye Option for Dual-Head Variable Angle Gamma CameraGe Medical Systems F.I. Haifa · 1999 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
K953801VaricamElscint, Inc. · 1995 · 3 generations back · ◆ in the 1995 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 2.7 years on median.
13 of the 30 ancestors have a recall of any class; 5 have a Class I recall.
Of its descendants, K212004 (GE Healthcare, 2021) has gone furthest, with 0 descendants of its own.

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 intended use of the Ventri 1.1 system is to perform nuclear imaging procedures for

detection and imaging of radioisotope tracer uptake in the patient body for clinical

diagnostic purposes.

Ventri 1.1 is primarily intended for cardiac applications

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K080124 · printed Nov 4, 2026

Cite this page

510(k) Report. “K080124: Ventri 1.1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K080124

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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