The following data is part of a premarket notification filed by Siemens Ag with the FDA for Flex Loop Coil Set 3t.
| Device ID | K063373 |
| 510k Number | K063373 |
| Device Name: | FLEX LOOP COIL SET 3T |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | SIEMENS AG HENKESTRASSE 127 Erlangen, DE D-91052 |
| Contact | Ruth Schneiss |
| Correspondent | Stefan Preiss TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-11-08 |
| Decision Date | 2006-11-17 |
| Summary: | summary |