The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Somatom Force, Somatom Definition Flash, Somatom Definition Edge, Somatom Definition As/as+, Somatom Definition As Open, Somaton Emotion 6/16, Somatom Sensation 64/sensation Cardiac , Somatom Perspective Somatom Scope/ Scope Power.
Device ID | K142955 |
510k Number | K142955 |
Device Name: | SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATON Emotion 6/16, SOMATOM Sensation 64/Sensation Cardiac , SOMATOM Perspective SOMATOM Scope/ Scope Power |
Classification | System, X-ray, Tomography, Computed |
Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. Malvern, PA 19355 |
Contact | Kimberly Mangum |
Correspondent | Kimberly Mangum SIEMENS MEDICAL SOLUTIONS 51 VALLEY STREAM PARKWAY Malvern, PA 19355 |
Product Code | JAK |
CFR Regulation Number | 892.1750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-10-14 |
Decision Date | 2015-11-24 |
Summary: | summary |