The following data is part of a premarket notification filed by Siemens Medical Solutions Usa Inc. with the FDA for 31p/1h Headcoil For Magnetom Allegra.
| Device ID | K042617 |
| 510k Number | K042617 |
| Device Name: | 31P/1H HEADCOIL FOR MAGNETOM ALLEGRA |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA INC. 51 VALLEY STREAM PARKWAY E-50 Malvern, PA 19355 |
| Contact | Nealie Hartman |
| Correspondent | Nealie Hartman SIEMENS MEDICAL SOLUTIONS USA INC. 51 VALLEY STREAM PARKWAY E-50 Malvern, PA 19355 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-24 |
| Decision Date | 2004-11-05 |
| Summary: | summary |