The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Somatom Perspective.
Device ID | K113287 |
510k Number | K113287 |
Device Name: | SOMATOM PERSPECTIVE |
Classification | System, X-ray, Tomography, Computed |
Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. Malvern, PA 19355 -1406 |
Contact | Kim Mangum |
Correspondent | Kim Mangum 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 | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-11-07 |
Decision Date | 2012-05-23 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SOMATOM PERSPECTIVE 79107827 4177698 Live/Registered |
Siemens Healthcare GmbH 2011-11-14 |