510(k) · Cleared
Recalled · Class II · 2017GE Discovery NM/CT 570C
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 Dec 12, 2008 as substantially equivalent to K080124 (Ge Medical Systems F.I. Haifa, 2008) and 3 other predicates after a 16-day review. Its family tree reaches back 6 generations to 1995. 5 of the 40 devices in its family, counting itself, have a Class I recall. It has been recalled once.
- Decided
- Dec 12, 2008
- Review
- 16 days
- Class
- Class II
- Product code
- KPS
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 6 generations to K952674 (1995). 39 ancestors in all, the oldest K885054 (1989). No later device cites it as a predicate yet. 5 of the 40 devices in this family, counting this one, have a Class I recall.
- Root · 6 generations backK952674 Transact: Attenuation Correction System for the Apex Cardial Gamma…Elscint, Inc. · 1995 · Recalled
- 5 generations backK980959 Vtransact: Attenuation Correction System for Dual-Head Variable…Ge Medical Systems F.I. Haifa · 1998
- 4 generations backK991841 Hawkeye Option for Dual-Head Variable Angle Gamma CameraGe Medical Systems F.I. Haifa · 1999 · Recalled (Class I)
- 3 generations backK022960 GE Quasar Nuclear Medicine SystemGe Medical Systems F.I. Haifa · 2002 · Recalled (Class I)
- 2 generations backK051855 VentriGe Medical Systems F.I. Haifa · 2005 · Recalled
- 1 generation backK080124 Ventri 1.1Ge Medical Systems F.I. Haifa · 2008 · Recalled
- This deviceK083504 GE Discovery NM/CT 570CGe Medical Systems F.I. Haifa · 2008
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K952674 | Transact: Attenuation Correction System for the Apex Cardial Gamma Camera | Elscint, Inc. | 1995 | 1 |
| −5 | K980959 | Vtransact: Attenuation Correction System for Dual-Head Variable Angle Gamma… | Ge Medical Systems F.I. Haifa | 1998 | — |
| −4 | K991841 | Hawkeye Option for Dual-Head Variable Angle Gamma Camera | Ge Medical Systems F.I. Haifa | 1999 | Class I |
| −3 | K022960 | GE Quasar Nuclear Medicine System | Ge Medical Systems F.I. Haifa | 2002 | Class I |
| −2 | K051855 | Ventri | Ge Medical Systems F.I. Haifa | 2005 | 3 |
| −1 | K080124 | Ventri 1.1 | Ge Medical Systems F.I. Haifa | 2008 | 2 |
| 0 (this device) | K083504 | GE Discovery NM/CT 570C | Ge Medical Systems F.I. Haifa | 2008 | — |
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 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 4 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 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.
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 18.6 · 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? (4)
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 |
|---|---|---|---|
| * | K080124 | Ventri 1.1Summary page 1…vices. Identification of Leealiv Marketed Eguivalent Devices Device Name K Number Feature Ventri 1.1 K080124 SPECT system LightSpeed 7.1 K061817 CT system Xeleris 2 K051673… | 2008 |
| * | K061817 | Lightspeed 7.1 CT Scanner SystemSummary page 1…Device Name K Number Feature Ventri 1.1 K080124 SPECT system LightSpeed 7.1 K061817 CT system Xeleris 2 K051673 Processing and Review Workstation for… | 2006 |
| * | K043381 | Infinia LightspeedSummary page 1…51673 Processing and Review Workstation for Xeleris 2KOS 1673 SPECT, CT and Hybrid SPECT-CT Infinia LightSpeed K043381 Hybrid SPECT-CT Page 31 of 36 GE Discovery NMCT 570c 510kPremarket Notifi… | 2004 |
| * | K051673 | Xeleris 2 Processing and Review WorkstationSummary page 1…Feature Ventri 1.1 K080124 SPECT system LightSpeed 7.1 K061817 CT system Xeleris 2 K051673 Processing and Review Workstation for Xeleris 2KOS 1673 SPECT, CT and Hybrid SPECT-CT… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (5 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 19, 2017 | Class II | Z-2196-2017 | Software design | It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed. |
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 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- 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
- K914807Apex Helix - aElscint, Inc. · 1992 · 2 generations back · ◆ in the 1992 ancestors bar of FIG. 11 Class I recall
- K962738Millennium MT and Millennium MG Nuclear Medicine SystemsGE Medical Systems · 1996 · 3 generations back · ◆ in the 1996 ancestors bar of FIG. 13 Class I recalls
- 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.
- 20 of the 39 ancestors have a recall of any class; 5 have a Class I recall.
- 1 other device also cites its predicate K080124.
How does its category compare?
All KPS devicesKPS 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
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 GE Discovery NM/CT 570c system is primarily to perform combined cardiac SPECT and CT diagnostic imaging applications, including CT-based SPECT attenuation correction and functional-anatomical mapping (registration and fusion).
The GE Discovery NM/CT 570c system intended uses include performing nuclear cardiac imaging procedures for detection and imaging of radioisotope tracer uptake in the patient body for clinical diagnostic purposes as well as performing general Head & Body Computed Tomography (CT) applications
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083504 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083504: GE Discovery NM/CT 570C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083504
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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