The following data is part of a premarket notification filed by Siemens Corp. with the FDA for E. Cam Profile Attenuation Correction.
| Device ID | K963983 |
| 510k Number | K963983 |
| Device Name: | E. CAM PROFILE ATTENUATION CORRECTION |
| Classification | System, Tomography, Computed, Emission |
| Applicant | SIEMENS CORP. 2501 NORTH BARRINGTON RD. Hoffman Estates, IL 60195 -7372 |
| Contact | Paul G Oris |
| Correspondent | Paul G Oris SIEMENS CORP. 2501 NORTH BARRINGTON RD. Hoffman Estates, IL 60195 -7372 |
| Product Code | KPS |
| CFR Regulation Number | 892.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-04 |
| Decision Date | 1997-03-31 |