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510(k) K081859

MODIFICATION TO ONEDOSE PATIENT DOSIMETRY SYSTEM by Sicel Technologies, Inc. — Product Code IYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 2008
Date Received
July 1, 2008
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accelerator, Linear, Medical
Device Class
Class II
Regulation Number
892.5050
Review Panel
RA
Submission Type

Other clearances by Sicel Technologies, Inc.

  • K083035 — DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM (November 13, 2008)
  • K080004 — DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM (January 23, 2008)
  • K071399 — DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODEL DVS-I-11: DVS INSERTION (June 20, 2007)
  • K061051 — DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODELS DVS-I-11, DVS INSERTIO (June 13, 2006)
  • K052118 — DOSE VERIFICATION SYSTEM (April 3, 2006)
  • K040687 — ONEDOSE PATIENT DOSIMETRY SYSTEM (June 25, 2004)

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