The following data is part of a premarket notification filed by Philips Medical Systems North America Co. with the FDA for Doseright.
| Device ID | K012238 |
| 510k Number | K012238 |
| Device Name: | DOSERIGHT |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. 710 BRIDGEPORT AVE. Shelton, CT 06484 |
| Contact | Frank Gianelli |
| Correspondent | Frank Gianelli PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. 710 BRIDGEPORT AVE. Shelton, CT 06484 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-17 |
| Decision Date | 2001-10-01 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() DOSERIGHT 76705633 4027335 Live/Registered |
William Marsh Rice University 2010-12-09 |