JWMClass II

System, Tomographic, Nuclear

Radiology · 21 CFR 892.1310

MDR events20All time

Recalls1All time

Registered firms0Currently listed

510(k) clearances17All time

Recent MDR events

20 adverse event reports on file

Event type breakdown

Malfunction15

Other4

Unspecified1

Most-reported manufacturers

Siemens Medical Systems, Inc. Nmg Group4 Smv International4 Smv America3 Siemens Medical Systems2 *1 Adac Laboratories1 Siemens Medical Systems, Inc., Ngm Group1 Siemens Medical Systems, Inc., Nmg Group1

Recalls

1 recall events for this product code

Siemens Medical Solutions USA, Inc.
TerminatedApr 16, 2003
ICON 9.5 Software used on the ICON workstations designed for use with the E.CAM Emission Imaging Computed Tomography Systems; Siemens Medical Systems, Inc., Nuc
ICON 9.5 software does not apply flood corrections during whole body SPECT studies with multiple bed positions.
Z-0727-03 · View FDA record ↗

Registered firms

0 firms currently registered for this product code

No registered firms found for this product code.

510(k) clearances

17 clearances for this product code