The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Dynapbv Body Software.
Device ID | K121292 |
510k Number | K121292 |
Device Name: | DYNAPBV BODY SOFTWARE |
Classification | System, Image Processing, Radiological |
Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. Malvern, PA 19355 -1406 |
Contact | Patricia D Jones |
Correspondent | Patricia D Jones SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. Malvern, PA 19355 -1406 |
Product Code | LLZ |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-04-30 |
Decision Date | 2012-07-30 |
Summary: | summary |