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510(k) K080004

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

K080004 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 January 23, 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
January 23, 2008
Date Received
January 2, 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.

  • K083035 — DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM (November 13, 2008)
  • K081859 — MODIFICATION TO ONEDOSE PATIENT DOSIMETRY SYSTEM (August 4, 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)
  • K083035 — DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM (November 13, 2008)

FDA data resources