MILLENNIUM MT AND MILLENNIUM MG NUCLEAR MEDICINE SYSTEMS— 510(k) K962738
Substantially EquivalentGE Medical Systems
FDA 510(k) clearance K962738 for MILLENNIUM MT AND MILLENNIUM MG NUCLEAR MEDICINE SYSTEMS, Substantially Equivalent on 1996-10-10. Applicant: GE Medical Systems. Device class: 2.
Clearance details
- Applicant
- GE Medical Systems
- 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
- Milwaukee, WI, US
Recent devices under product code KPS
view allMore clearances from GE Medical Systems
view allRecalls naming K962738
K-number listed on FDA's recall record- Z-0369-2019 — GE Healthcare Millennium MyoSIGHT Nuclear Cardiology Imaging System H3000ZH Acquisition System
- Z-0370-2019 — GE Healthcare Millennium MG Multi-Geometry Digital CSE Dual Detector Gamma Camera H3000ZL Acquisition System
- Z-0371-2019 — GE Healthcare Millennium MC
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K962738.
Data sourced from openFDA. This site is unofficial and independent of the FDA.