The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Syngo Colonography Software Package.
| Device ID | K030982 |
| 510k Number | K030982 |
| Device Name: | SYNGO COLONOGRAPHY SOFTWARE PACKAGE |
| Classification | System, Image Processing, Radiological |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. Malvern, PA 19355 -1406 |
| Contact | Jamie Yieh |
| Correspondent | Heinz Joerg Steneberg TUV RHEINLAND OF NORTH AMERICA, INC. 12 COMMERCE RD. Newton, CT 06470 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-03-28 |
| Decision Date | 2003-04-08 |
| Summary: | summary |