The following data is part of a premarket notification filed by Sicel Technologies, Inc. with the FDA for Dose Verification System Patient Dosimetry System, Models Dvs-i-11, Dvs Insertion Tool, Dvs-d-a, Dvs Dosimeter.
| Device ID | K061051 |
| 510k Number | K061051 |
| Device Name: | DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODELS DVS-I-11, DVS INSERTION TOOL, DVS-D-A, DVS DOSIMETER |
| Classification | System, Radiation Therapy, Charged-particle, Medical |
| Applicant | SICEL TECHNOLOGIES, INC. 3800 GATEWAY CENTRE BLVD. SUITE 308 Morrisville, NC 27560 |
| Contact | Tammy B Carrea |
| Correspondent | Tammy B Carrea SICEL TECHNOLOGIES, INC. 3800 GATEWAY CENTRE BLVD. SUITE 308 Morrisville, NC 27560 |
| Product Code | LHN |
| CFR Regulation Number | 892.5050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-17 |
| Decision Date | 2006-06-13 |
| Summary: | summary |