510(k) · Cleared
Recalled · Class II · 2024MyoSPECT, MyoSpect ES
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Healthcare · KPS System, Tomography, Computed, Emission
Cleared on Aug 27, 2021 as substantially equivalent to K080124 (Ge Medical Systems F.I. Haifa, 2008) after a 60-day review. Its family tree reaches back 6 generations to 1995. 5 of the 32 devices in its family, counting itself, have a Class I recall. It has been recalled once.
- Decided
- Aug 27, 2021
- Review
- 60 days
- Class
- Class II
- Product code
- KPS
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 6 generations to K952674 (1995). 31 ancestors in all, the oldest K885054 (1989). No later device cites it as a predicate yet. 5 of the 32 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 deviceK212004 MyoSPECT, MyoSpect ESGE Healthcare · 2021
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) | K212004 | MyoSPECT, MyoSpect ES | GE Healthcare | 2021 | — |
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 |
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? (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 | Decided |
|---|---|---|---|
| * | K080124 | Ventri 1.1Summary page 5…Predicate Device Information Device Name: Ventri 1.1 Manufacturer: GE Medical Systems Israel, Functional Imaging 510(k) Number: K080124 Regulation Number / 21CFR 892.1200 Product Code: 90 KPS Note: The current production of Ventri 1.1 is comme… | 2008 |
| † | K111445 | Discovery NM 630 | 2011 |
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 |
|---|---|---|---|---|
| Apr 15, 2024 | Class II | Z-2040-2024 | Device Design | There is a potential issue regarding the service handles for the internal lead (Pb) covers in that the handles could loosen or release which could cause a cover to drop potentially resulting in injury to service personnel due to the… |
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 · 2 generations back · ◆ in the 1992 ancestors bar of FIG. 11 Class I recall
- K022960GE Quasar Nuclear Medicine SystemGe Medical Systems F.I. Haifa · 2002 · 3 generations back · ◆ on the line of descent in 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
- K991841Hawkeye Option for Dual-Head Variable Angle Gamma CameraGe Medical Systems F.I. Haifa · 1999 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K953801VaricamElscint, Inc. · 1995 · 4 generations back · ◆ in the 1995 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 26 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- 14 of the 31 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. 2021, 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 GE MyoSPECT and MyoSPECT ES systems are a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing and diagnosing of cardiac diseases and heart function for the evaluation of diseases, abnormalities, and disorders. The systems output can also be used by the physician for planning, guiding, and monitoring. MyoSPECT and MyoSPECT ES perform Nuclear Medicine (NM) imaging procedures for the detection…
Read the full statement (160 words)
The GE MyoSPECT and MyoSPECT ES systems are a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing and diagnosing of cardiac diseases and heart function for the evaluation of diseases, abnormalities, and disorders. The systems output can also be used by the physician for planning, guiding, and monitoring.
MyoSPECT and MyoSPECT ES perform Nuclear Medicine (NM) imaging procedures for the detection of radioisotope tracer uptake in the patient body, using tomographic scanning of single or multi-isotopes with either single or multi energy peaks. The tomographic scanning is supported by various acquisition types.
The GE MyoSPECT and MyoSPECT ES systems include signal analysis and display equipment, patient and equipment supports, components and accessories. The systems may include data and image processing to produce reconstructed trans-axial images. The images can also be post processed to obtain additional images, imaging planes, analysis results and uptake quantitation.
The systems may be used for patients of all ages.
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/K212004 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212004: MyoSPECT, MyoSpect ES.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212004
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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