The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Biograph 64 And Biograph 40.
| Device ID | K060631 |
| 510k Number | K060631 |
| Device Name: | BIOGRAPH 64 AND BIOGRAPH 40 |
| Classification | System, Tomography, Computed, Emission |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 810 INNOVATION DR. Knoxville, TN 37932 |
| Contact | Alaine Medio |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-03-09 |
| Decision Date | 2006-03-17 |
| Summary: | summary |