The following data is part of a premarket notification filed by Siemens Medical Solutions Health Services Corporat with the FDA for Medical Image Management System/x-ray Terminal.
Device ID | K933098 |
510k Number | K933098 |
Device Name: | MEDICAL IMAGE MANAGEMENT SYSTEM/X-RAY TERMINAL |
Classification | System, Digital Image Communications, Radiological |
Applicant | SIEMENS MEDICAL SOLUTIONS HEALTH SERVICES CORPORAT 51 VALLEY STREAM PKWY. Malvern, PA 19355 |
Contact | Sheryl Dyner |
Correspondent | Sheryl Dyner SIEMENS MEDICAL SOLUTIONS HEALTH SERVICES CORPORAT 51 VALLEY STREAM PKWY. Malvern, PA 19355 |
Product Code | LMD |
CFR Regulation Number | 892.2020 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-06-24 |
Decision Date | 1993-09-20 |