The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Somatom Extended Field Of View Software Option.
| Device ID | K032536 |
| 510k Number | K032536 |
| Device Name: | SOMATOM EXTENDED FIELD OF VIEW SOFTWARE OPTION |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. Malvern, PA 19355 -1406 |
| Contact | Nealie K Hartman |
| Correspondent | Nealie K Hartman SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. Malvern, PA 19355 -1406 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-18 |
| Decision Date | 2003-11-10 |
| Summary: | summary |