Discovery NM/CT 670 CZT— 510(k) K153402
Substantially EquivalentGE Healthcare
FDA 510(k) clearance K153402 for Discovery NM/CT 670 CZT, Substantially Equivalent on 2016-01-21. Applicant: GE Healthcare. Device class: 2.
Clearance details
- Applicant
- GE Healthcare
- Product code
- Code KPS
- Device class
- Class 2
- Regulation
- 21 CFR 892.1200
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tirat Hacarmel, IL
Recent devices under product code KPS
view allMore clearances from GE Healthcare
view allRecalls naming K153402
K-number listed on FDA's recall record- Z-1057-2023 — GE Nuclear Medicine 600/800 series systems, specifically: a) 870 CZT O540+ Gantry 7.25mm, b) D670 CZT Gantry 7.25mm, c) DISCOV NM/CT 870 CZT, d) Discovery NMCT 670 CZT O540+, e) NM/CT 870 CZT CYBER DEFENCE, f) NM/CT 870 CZT O540, g) NM/CT 870 CZT WSO, h) NM/CT 870 CZT, i) NM/CT 870 CZT O540+ 7.25MM; Emission Computed Tomography System
- Z-0855-2021 — GE NM/CT 870 CZT system Model Number H3906CW - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.
- Z-2993-2020 — NM/CT 870 CZT Model # H3906CW
- Z-1258-2019 — Discovery NM/CT 670 CZT, Model/Catalogue/Code H3906CT Product Usage: The GE Discovery NM/CT 670 CZT system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine system using a variety of scanning modes supported by various acquisition types, and a Computed Tomography system which is intended for enabling attenuation correction and anatomical localization of SPECT images and for standalone head, whole body, cardiac and vascular X-ray Computed Tomography applications.
- Z-1264-2019 — NM/CT 870 CZT, Model/Catalogue/Code # H3906CW Product Usage: The GE Discovery NM/CT 670 CZT system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine system using a variety of scanning modes supported by various acquisition types, and a Computed Tomography system which is intended for enabling attenuation correction and anatomical localization of SPECT images and for standalone head, whole body, cardiac and vascular X-ray Computed Tomography applications.
- Z-2195-2017 — GE Healthcare Discovery NM/CT 670 CZT X-ray system
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K153402.
Data sourced from openFDA. This site is unofficial and independent of the FDA.