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FDA 510(k), K061051, DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODELS DVS-I-11, DVS INSERTION TOOL, DVS-D-A, DVS DOSIMETER
FDA 510(k), K061051, DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODELS DVS-I-11, DVS INSERTION TOOL, DVS-D-A, DVS DOSIMETER
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510(K) Number: K061051
Device Name: DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODELS DVS-I-11, DVS INSERTION TOOL, DVS-D-A, DVS DOSIMETER
Manufacturer: SICEL TECHNOLOGIES, INC.
Device Classification Name: system, radiation therapy, charged-particle, medical
Regulation Number: 892.5050
Classification Product Code: LHN
Date Received: 04/17/2006
Decision Date: 06/13/2006
Regulation Medical Specialty: Radiology
Device Name: DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODELS DVS-I-11, DVS INSERTION TOOL, DVS-D-A, DVS DOSIMETER
Manufacturer: SICEL TECHNOLOGIES, INC.
Device Classification Name: system, radiation therapy, charged-particle, medical
Regulation Number: 892.5050
Classification Product Code: LHN
Date Received: 04/17/2006
Decision Date: 06/13/2006
Regulation Medical Specialty: Radiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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