OPDIMA
System, X-ray, Mammographic
SIEMENS MEDICAL SOLUTIONS USA, INC.
The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Opdima.
Pre-market Notification Details
| Device ID | K003945 |
| 510k Number | K003945 |
| Device Name: | OPDIMA |
| Classification | System, X-ray, Mammographic |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 186 WOOD AVENUE SOUTH Iselin, NJ 08830 |
| Contact | Praveen Nadkarni |
| Correspondent | Praveen Nadkarni SIEMENS MEDICAL SOLUTIONS USA, INC. 186 WOOD AVENUE SOUTH Iselin, NJ 08830 |
| Product Code | IZH |
| CFR Regulation Number | 892.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-21 |
| Decision Date | 2001-02-02 |
Trademark Results [OPDIMA]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OPDIMA 75332591 2217083 Live/Registered |
SIEMENS HEALTHCARE GMBH 1997-07-29 |
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