The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Biograph Mct And Mct Flow Pet/ct Scanners.
| Device ID | K151486 |
| 510k Number | K151486 |
| Device Name: | Biograph MCT And MCT Flow PET/CT Scanners |
| Classification | System, Tomography, Computed, Emission |
| Applicant | Siemens Medical Solutions USA, Inc. 810 INNOVATION DRIVE Knoxville, TN 37932 |
| Contact | Alaine Medio |
| Correspondent | Alaine Medio Siemens Medical Solutions USA, Inc. 810 INNOVATION DRIVE Knoxville, TN 37932 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-02 |
| Decision Date | 2015-07-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869001890 | K151486 | 000 |
| 04056869001883 | K151486 | 000 |
| 04056869001876 | K151486 | 000 |
| 04056869001869 | K151486 | 000 |
| 04056869001852 | K151486 | 000 |
| 04056869001845 | K151486 | 000 |
| 04056869001395 | K151486 | 000 |
| 04056869001289 | K151486 | 000 |