The following data is part of a premarket notification filed by .decimal, Inc. with the FDA for .decimal Photon Block.
| Device ID | K123015 |
| 510k Number | K123015 |
| Device Name: | .DECIMAL PHOTON BLOCK |
| Classification | Block, Beam-shaping, Radiation Therapy |
| Applicant | .DECIMAL, INC. 121 CENTRAL PARK PLACE Sanford, FL 32771 |
| Contact | Kym Rupp |
| Correspondent | Kym Rupp .DECIMAL, INC. 121 CENTRAL PARK PLACE Sanford, FL 32771 |
| Product Code | IXI |
| CFR Regulation Number | 892.5710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-28 |
| Decision Date | 2012-11-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851147007045 | K123015 | 000 |