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510(k) K083035

DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM by Sicel Technologies, Inc. — Product Code NZT

K083035 is an FDA 510(k) premarket notification submitted by Sicel Technologies, Inc. for the device "DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM". The FDA issued a decision of Substantially Equivalent on November 13, 2008. The device falls under product code NZT (Dosimeter, Ionizing Radiation, Implanted), a Class II device regulated under 21 CFR 892.5050. Sicel Technologies, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 2008
Date Received
October 14, 2008
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dosimeter, Ionizing Radiation, Implanted
Device Class
Class II
Regulation Number
892.5050
Review Panel
RA
Submission Type

Verify radiation dose to organs from external radiation therapy.

Other clearances by Sicel Technologies, Inc.

  • K081859 — MODIFICATION TO ONEDOSE PATIENT DOSIMETRY SYSTEM (August 4, 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)

Other clearances for product code NZT

  • K250083 — PRO-DOSE System (October 1, 2025)
  • K182395 — OARtrac System (March 22, 2019)
  • K162954 — OARtrac System with Patient Specific Reusable Universal PSD Sensors (June 1, 2017)
  • K150719 — OARtrac System with Skin Sensors (June 16, 2015)
  • K141154 — OARTRAC SYSTEM (July 22, 2014)
  • K080004 — DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM (January 23, 2008)

FDA data resources