The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Ai-rad Companion (cardiovascular).
Device ID | K183268 |
510k Number | K183268 |
Device Name: | AI-Rad Companion (Cardiovascular) |
Classification | System, X-ray, Tomography, Computed |
Applicant | Siemens Medical Solutions USA, Inc. 40 Liberty Blvd. Malvern, PA 19355 |
Contact | Kimberly Rendon |
Correspondent | Kimberly Rendon Siemens Medical Solutions USA, Inc. 40 Liberty Blvd. 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 | 2018-11-23 |
Decision Date | 2019-09-10 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04056869251226 | K183268 | 000 |
04056869297286 | K183268 | 000 |