The following data is part of a premarket notification filed by Oncology Systems, Inc. with the FDA for Acu007s.
| Device ID | K092522 |
| 510k Number | K092522 |
| Device Name: | ACU007S |
| Classification | Source, Brachytherapy, Radionuclide |
| Applicant | ONCOLOGY SYSTEMS, INC. 206 N RANDOLPH STREET, STE 301 Champaign, IL 61820 |
| Contact | Jennifer Williams |
| Correspondent | Jennifer Williams ONCOLOGY SYSTEMS, INC. 206 N RANDOLPH STREET, STE 301 Champaign, IL 61820 |
| Product Code | KXK |
| CFR Regulation Number | 892.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-18 |
| Decision Date | 2009-11-20 |
| Summary: | summary |