The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Mri Soft Tissue Motion Correction Software Va10a.
| Device ID | K052305 |
| 510k Number | K052305 |
| Device Name: | MRI SOFT TISSUE MOTION CORRECTION SOFTWARE VA10A |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 45 STILES ROAD Salem, NH 03079 |
| Contact | Barry V Ashar |
| Correspondent | Laura Danielson TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-08-24 |
| Decision Date | 2005-09-08 |
| Summary: | summary |