The following data is part of a premarket notification filed by Oncology Systems, Inc. with the FDA for Accu-source.
| Device ID | K051753 |
| 510k Number | K051753 |
| Device Name: | ACCU-SOURCE |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | ONCOLOGY SYSTEMS, INC. 206 N RANDOLPH STREET, STE 300 Champaign, IL 61820 |
| Contact | Jennifer Williams |
| Correspondent | Jennifer Williams ONCOLOGY SYSTEMS, INC. 206 N RANDOLPH STREET, STE 300 Champaign, IL 61820 |
| Product Code | JAQ |
| CFR Regulation Number | 892.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-29 |
| Decision Date | 2006-03-29 |
| Summary: | summary |