The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Ai-rad Companion Organs Rt.
Device ID | K193562 |
510k Number | K193562 |
Device Name: | AI-Rad Companion Organs RT |
Classification | Radiological Image Processing Software For Radiation Therapy |
Applicant | Siemens Medical Solutions USA, Inc. 40 Liberty Blvd. Mail Code 65-3 Malvern, PA 19355 |
Contact | Lauren Bentley |
Correspondent | Lauren Bentley Siemens Medical Solutions USA, Inc. 40 Liberty Blvd. Mail Code 65-3 Malvern, PA 19355 |
Product Code | QKB |
CFR Regulation Number | 892.2050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-12-23 |
Decision Date | 2020-11-06 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04056869257969 | K193562 | 000 |
04056869274645 | K193562 | 000 |