The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Symbia 6.0.
| Device ID | K142006 |
| 510k Number | K142006 |
| Device Name: | SYMBIA 6.0 |
| Classification | System, Tomography, Computed, Emission |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 2501 NORTH BARRINGTON RD. Hoffman Estates, IL 60192 |
| Contact | Cynthia Busch |
| Correspondent | Cynthia Busch SIEMENS MEDICAL SOLUTIONS USA, INC. 2501 NORTH BARRINGTON RD. Hoffman Estates, IL 60192 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-23 |
| Decision Date | 2014-08-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869002323 | K142006 | 000 |
| 04056869001906 | K142006 | 000 |
| 04056869001913 | K142006 | 000 |
| 04056869001920 | K142006 | 000 |
| 04056869001937 | K142006 | 000 |
| 04056869001944 | K142006 | 000 |
| 04056869001951 | K142006 | 000 |
| 04056869001968 | K142006 | 000 |
| 04056869001975 | K142006 | 000 |
| 04056869001982 | K142006 | 000 |
| 04056869001999 | K142006 | 000 |
| 04056869002002 | K142006 | 000 |
| 04056869002019 | K142006 | 000 |
| 04056869002026 | K142006 | 000 |
| 04056869002033 | K142006 | 000 |
| 04056869002040 | K142006 | 000 |
| 04056869002057 | K142006 | 000 |
| 04056869002064 | K142006 | 000 |
| 04056869001234 | K142006 | 000 |