The following data is part of a premarket notification filed by Oncology Tech, Llc with the FDA for Mod1t Compensators For Radiation Beam Therapy.
| Device ID | K091403 |
| 510k Number | K091403 |
| Device Name: | MOD1T COMPENSATORS FOR RADIATION BEAM THERAPY |
| Classification | Block, Beam-shaping, Radiation Therapy |
| Applicant | ONCOLOGY TECH, LLC 5608 BUSINESS PARK San Antonio, TX 78218 |
| Contact | Sean Comer |
| Correspondent | Sean Comer ONCOLOGY TECH, LLC 5608 BUSINESS PARK San Antonio, TX 78218 |
| Product Code | IXI |
| CFR Regulation Number | 892.5710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-12 |
| Decision Date | 2009-07-29 |
| Summary: | summary |