2 results
·
16ms
·
Sources: EU EUDAMED, US FDA
Filters
Classification: Class I
×
GE Nuclear Medicine 600/800 series systems, specifically: a) 870, b) 870 DR 3/8 inch NM GANTRY WITH NEW ROTOR - MEA, c) 870 DR / Dismount, d) 870 DR / Dismount / 60HZ, e) 870 DR 3/8 inch WSO, f) 870 DR 3/8 inch NM Gantry, g) 870 DR 3/8 inch, h) 870 DR 3/8 inch CH, i) 870 DR 5/8 inch NM GANTRY, j) 870 DR BJ / Dismount, k) 870 DR CyberDefense 3/8 inch NM Gantry, l) 870 DR NM GANTRY FINAL - NEW ROTOR, m) 870 DR China, n) D670 NM GANTRY WITH NEW ROTOR, o) D670 DR 3/8 inch 16 SL, p) D670 DR 3/8 inch MEA, q) D670 DR 3/8 inch, r) D670 DR 3/8 inch 16SL, s) D670 DR 3/8 inch 16SL NR, t) D670 DR 3/8 inch BJ, u) D670 DR 3/8 inch MEA, v) D670 DR NM Gantry 3/8 inch, w) D670 DR NM Gantry 5/8 inch, x) D670 DR with new rotor, y) D670 ES NM Gantry 3/8 inch, z) D670 ES NM/CT 3/8 inch O540+ NM Gantry, aa) D670 ES NM/CT DR 3/8 inch, bb) D670 GANTRY, cc) D670 PRO NM Gantry 3/8 inch, dd) D670 PRO NM GANTRY 3/8 inch, ee) DISC NM/CT670 DR 3/8 inch, ff) DISC NM/CT870 DR 3/8 inch, gg) DISC NM/CT870 DR 3/8 inch, hh) DISC NM/CT870 DR 5/8 inch, ii) DISCOVERY 670 (TANDEM), jj) DISCOVERY NM 670, kk) DISCOVERY NM/CT 670 3/8 inch PRO, ll) DISCOVERY NM/CT 670 3/8 inch PRO NR, mm) HP Z420 WS Config 1 Hardware Specs Take 3 - E5-1620-8G-1TB-NVS, nn) NM/CT 870 DR, oo) NM/CT 870 DR 3/8 inch CYBER DEFENCE, pp) NM/CT 870 DR 3/8 inch WSO, qq) NM/CT 870 DR O540 3/8 inch, rr) NM/CT 870 DR O540 3/8 inch BJ, ss) NM/CT 870 DR O540 5/8 inch, tt) NM/CT 870 ES 3/8 inch, uu) NM/CT 870DR China for China, vv) NM/CT870 DR 3/8 inch O540, ww) NM/CT D870 DR O540 3/8 inch, xx) TANDEM DISCOVERY 670 INT; Emission Computed Tomography System
FDA Enforcement
Class I
·Ongoing·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING·February 15, 2023
Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);
FDA Enforcement
Class I
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025