The following data is part of a premarket notification filed by Acceletronics Digital Imaging, Llc. with the FDA for Rad Ii Simulator, Rad Ii Kv Imager, Dual Rad Ii Kv Imager.
| Device ID | K101038 |
| 510k Number | K101038 |
| Device Name: | RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGER |
| Classification | System, Simulation, Radiation Therapy |
| Applicant | ACCELETRONICS DIGITAL IMAGING, LLC. 602 GORDON DR Exton, PA 19341 |
| Contact | Steve Schwarz |
| Correspondent | Steve Schwarz ACCELETRONICS DIGITAL IMAGING, LLC. 602 GORDON DR Exton, PA 19341 |
| Product Code | KPQ |
| CFR Regulation Number | 892.5840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-14 |
| Decision Date | 2010-08-17 |
| Summary: | summary |