# K212004: MyoSPECT, MyoSpect ES

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Aug 27, 2021 after 60 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K952674 (1995). 31 ancestors in all.
No later device cites it as a predicate yet.
5 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080124: Ventri 1.1, Ge Medical Systems F.I. Haifa (2008) Summary page 5.

## Recalls of this device
- Apr 15, 2024 · Class II · Z-2040-2024: 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

## Indications for use
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.

Source page: https://510kreport.com/device/K212004
Methodology: https://510kreport.com/methodology