The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Or Head Coil 1.5 T.
| Device ID | K060758 |
| 510k Number | K060758 |
| Device Name: | OR HEAD COIL 1.5 T |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. Malvern, PA 19355 -1406 |
| Contact | Judith Campbell |
| Correspondent | Judith Campbell SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. Malvern, PA 19355 -1406 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-21 |
| Decision Date | 2006-05-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04251269204975 | K060758 | 000 |
| 04251269206788 | K060758 | 000 |
| 04251269206818 | K060758 | 000 |
| 04251269206825 | K060758 | 000 |
| 04251269206191 | K060758 | 000 |
| 04251269205880 | K060758 | 000 |
| 04251269202575 | K060758 | 000 |
| 04251269202582 | K060758 | 000 |
| 04251269202599 | K060758 | 000 |
| 04251269203718 | K060758 | 000 |
| 04251269203725 | K060758 | 000 |
| 04251269206771 | K060758 | 000 |