The following data is part of a premarket notification filed by Scanditronix, Inc. with the FDA for Dpd-510 Therapeutic Radiation Dosimeter.
| Device ID | K925133 |
| 510k Number | K925133 |
| Device Name: | DPD-510 THERAPEUTIC RADIATION DOSIMETER |
| Classification | System, Radiation Therapy, Radionuclide |
| Applicant | SCANDITRONIX, INC. HUSBYBORG, S-752 29 UPPSALA Sweden, SE |
| Contact | Lennart Ward |
| Correspondent | Lennart Ward SCANDITRONIX, INC. HUSBYBORG, S-752 29 UPPSALA Sweden, SE |
| Product Code | IWB |
| CFR Regulation Number | 892.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-13 |
| Decision Date | 1993-01-04 |