# K121019: Optima NM/CT 640

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Apr 19, 2012 after 15 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: 6 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K952674 (1995). 32 ancestors in all.
No later device cites it as a predicate yet.
7 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111445: Discovery NM 630, GE Healthcare (2011)
- K052434: Hawkeye 4 Option for Dual-Head Variable Angle Gamma Camera, GE Medical Systems (2005) Summary page 1.

## Recalls of this device
- Dec 18, 2024 · Class II · Z-0896-2025: GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details an
- Dec 19, 2022 · Class I · Z-1056-2023: A mitigation may not be correctly implemented. If this is the case, the detector can fall, leading to life-threatening bodily injury.
- Dec 10, 2020 · Class II · Z-0858-2021: GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector.
- Mar 20, 2019 · Class II · Z-1266-2019: During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading to the possible loss of one detector moun
- Oct 25, 2013 · Class II · Z-0367-2014: GE Healthcare has recently become aware of a potential safety issue related to a SPECT scan procedure used for pulmonary imaging. Contact between the Detector (GE Healthcare Discovery NM/CT 670, and/o
- Jun 13, 2013 · Class I · Z-1793-2013: GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System. UPDATE: 

## Indications for use
The GE Optima NM/CT 640 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and in assessment of organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy. The GE Optima NM/CT 640 system is a Nuclear Medicine (NM) system, which is intended to yield General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. The scanning modes include planar mode (Static, Multi-gated, Dynamic and Whole body scanning) and tomographic mode (SPECT, Gated SPECT, Whole body SPECT). The acquisition types include single and multi-isotope/multi peak frame/list mode single-photon imaging. The imaging-enhancement features include an assortment of collimators, gating by physiological signals, and real-time automatic body contouring. The GE Optima NM/CT 640 system includes an integrated CT, which is intended specifically for attenuation correction and anatomical localization purposes only, a processing and review workstation, and may include signal analysis and display equipment, patient and equipment supports, components and accessories. The system may be used for patients of all ages. Utilizing the associated CT portion and post processing, the device can produce attenuation corrected SPECT images using CT-based attenuation maps, as well as functional and anatomical mapping images registered with the SPECT images for purposes of localization and fusion. The device does not support stand-alone CT operation.

Source page: https://510kreport.com/device/K121019
Methodology: https://510kreport.com/methodology