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 (mim).
Device ID | K946117 |
510k Number | K946117 |
Device Name: | MEDICAL IMAGE MANAGEMENT SYSTEM (MIM) |
Classification | System, Image Processing, Radiological |
Applicant | SIEMENS MEDICAL SOLUTIONS HEALTH SERVICES CORPORAT 51 VALLEY STREAM PKWY. Malvern, PA 19355 |
Contact | Sheryl A Dyner |
Correspondent | Sheryl A Dyner SIEMENS MEDICAL SOLUTIONS HEALTH SERVICES CORPORAT 51 VALLEY STREAM PKWY. Malvern, PA 19355 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-12-15 |
Decision Date | 1995-03-02 |