510(k) · Cleared
Recalled · Class II · 2018Ventri
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems F.I. Haifa · KPS System, Tomography, Computed, Emission
Cleared on Aug 2, 2005 as substantially equivalent to K022960 (Ge Medical Systems F.I. Haifa, 2002) and 2 other predicates after a 25-day review. Its family tree reaches back 4 generations to 1995. 4 of the 15 devices in its family, counting itself, have a Class I recall. 3 later devices descend from it. It has been recalled 3 times.
- Decided
- Aug 2, 2005
- Review
- 25 days
- Class
- Class II
- Product code
- KPS
- Recalls
- 3
- Predicates
- 3
Its longest line of descent runs back 4 generations to K952674 (1995). 11 ancestors in all, the oldest K915470 (1992). 3 later devices descend from it, 1 citing it directly. 4 of the 15 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK952674 Transact: Attenuation Correction System for the Apex Cardial Gamma…Elscint, Inc. · 1995 · Recalled
- 3 generations backK980959 Vtransact: Attenuation Correction System for Dual-Head Variable…Ge Medical Systems F.I. Haifa · 1998
- 2 generations backK991841 Hawkeye Option for Dual-Head Variable Angle Gamma CameraGe Medical Systems F.I. Haifa · 1999 · Recalled (Class I)
- 1 generation backK022960 GE Quasar Nuclear Medicine SystemGe Medical Systems F.I. Haifa · 2002 · Recalled (Class I)
- This deviceK051855 VentriGe Medical Systems F.I. Haifa · 2005
- Descendant · cites it directly · 2 of its ownK080124 Ventri 1.1Ge Medical Systems F.I. Haifa · 2008 · Recalled
- Descendant · 2 generations on · 0 of its ownK212004 MyoSPECT, MyoSpect ESGE Healthcare · 2021 · Recalled
- Descendant · 2 generations on · 0 of its ownK083504 GE Discovery NM/CT 570CGe Medical Systems F.I. Haifa · 2008 · Recalled
Class I recalls in this family
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K952674 | Transact: Attenuation Correction System for the Apex Cardial Gamma Camera | Elscint, Inc. | 1995 | 1 |
| −3 | K980959 | Vtransact: Attenuation Correction System for Dual-Head Variable Angle Gamma… | Ge Medical Systems F.I. Haifa | 1998 | — |
| −2 | K991841 | Hawkeye Option for Dual-Head Variable Angle Gamma Camera | Ge Medical Systems F.I. Haifa | 1999 | Class I |
| −1 | K022960 | GE Quasar Nuclear Medicine System | Ge Medical Systems F.I. Haifa | 2002 | Class I |
| 0 (this device) | K051855 | Ventri | Ge Medical Systems F.I. Haifa | 2005 | — |
| +1 | K080124 | Ventri 1.1 | Ge Medical Systems F.I. Haifa | 2008 | 2 |
| +2 | K212004 | MyoSPECT, MyoSpect ES | GE Healthcare | 2021 | 1 |
| +2 | 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 |
|---|---|---|
| 1992 | 3 | 0 |
| 1995 | 2 | 1 |
| 1996 | 1 | 1 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2021 | 1 | 0 |
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 18.6 · 17 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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 | Decided |
|---|---|---|---|
| * | K022960 | GE Quasar Nuclear Medicine SystemSummary page 1…Modification of legally marketed devices. Identification of Legally Marketed Equivalent Devices GE Quasar Nuclear Medicine System ("Infinia") K022960 Optima Nuclear Medicine System K915470 Millennium MT and Millennium MG Nuclear Medicine System… | 2002 |
| * | K915470 | Optima Nuclear Tomography StystemSummary page 1…on of Legally Marketed Equivalent Devices GE Quasar Nuclear Medicine System ("Infinia") K022960 Optima Nuclear Medicine System K915470 Millennium MT and Millennium MG Nuclear Medicine Systems K96273… | 1992 |
| * | K962738 | Millennium MT and Millennium MG Nuclear Medicine SystemsSummary page 1…Medicine System K915470 Millennium MT and Millennium MG Nuclear Medicine Systems K962738 Page 32 of 37 9 GE Medical System,… | 1996 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080124 | Ventri 1.1 | 2008 | 2 |
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 30, 2018 | Class II | Z-2258-2020 | 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… |
| Nov 3, 2008 | Not classified | Z-2219-2009 | Process control | GE Healthcare become aware of an incident which caused a slight patient injury during his unload following a prone-oriented scan on Ventri. Although clear safety instructions were not followed in this case, additional measures will be… |
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.
- K022960GE Quasar Nuclear Medicine SystemGe Medical Systems F.I. Haifa · 2002 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K962738Millennium MT and Millennium MG Nuclear Medicine SystemsGE Medical Systems · 1996 · Direct predicate · ◆ 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 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K953801VaricamElscint, Inc. · 1995 · 2 generations back · ◆ in the 1995 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 2.9 years on median.
- 7 of the 11 ancestors have a recall of any class; 4 have a Class I recall.
- Of its descendants, K080124 (Ge Medical Systems F.I. Haifa, 2008) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K022960.
How does its category compare?
All KPS devicesKPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KPS
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KPS
65in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KPS
16in 2025
Class I (17 since 2007) Class II/III not classified
Adverse event reports per year · KPS
36in 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 system is to perform nuclear imaging procedures for detection and imaging of radioisotope tracer uptake in the patient body for clinical diagnostic purposes.
VENTRi is primarily intended for cardiac applications but also supports non-cardiac procedures of the patient's head, chest and body extremities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051855 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051855: Ventri.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051855
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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