The following data is part of a premarket notification filed by Siemens Medical Systems, Inc. with the FDA for Somatom Definition As Open.
| Device ID | K130901 |
| 510k Number | K130901 |
| Device Name: | SOMATOM DEFINITION AS OPEN |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | SIEMENS MEDICAL SYSTEMS, INC. 51 VALLEY STREAM PARKWAY Malvern, PA 19355 |
| Contact | Kimberly Mangum |
| Correspondent | Kimberly Mangum SIEMENS MEDICAL SYSTEMS, INC. 51 VALLEY STREAM PARKWAY Malvern, PA 19355 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-01 |
| Decision Date | 2014-01-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869003665 | K130901 | 000 |