The following data is part of a premarket notification filed by Oncology Systems, Inc. with the FDA for Onq Rts.
| Device ID | K123357 |
| 510k Number | K123357 |
| Device Name: | ONQ RTS |
| Classification | System, Planning, Radiation Therapy Treatment |
| Applicant | ONCOLOGY SYSTEMS, INC. 14 LONGBOW PROFESSIONAL CENTRE LONGBOW CLOSE Shrewsbury, Shropshire, GB Sy1 3gz |
| Contact | Carl Walker |
| Correspondent | Carl Walker ONCOLOGY SYSTEMS, INC. 14 LONGBOW PROFESSIONAL CENTRE LONGBOW CLOSE Shrewsbury, Shropshire, GB Sy1 3gz |
| Product Code | MUJ |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-31 |
| Decision Date | 2012-12-28 |
| Summary: | summary |