510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K083035Substantially Equivalent

Dose Verification System Patient Dosimetry System

Sicel Technologies, Inc., Morrisville NC / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K083035 is the FDA 510(k) clearance record for DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, a class II device, cleared for Sicel Technologies, Inc. on under FDA product code NZT (Dosimeter, Ionizing Radiation, Implanted). FDA's definition for product code NZT reads: "Verify radiation dose to organs from external radiation therapy". FDA records list 7 510(k) clearances for Sicel Technologies, Inc., from to . As of , FDA records show no recalls naming K083035.

Clearance record

Decision date
Received
(30 days to decision)
Product code
NZT Dosimeter, Ionizing Radiation, Implanted
Regulation
21 CFR 892.5050
Device class
Class II
Review panel
Radiology
Applicant
Sicel Technologies, Inc. 3800 Gateway Centre Blvd., Morrisville NC
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NZT

Trailing 12 months

FDA records hold no clearances under product code NZT in the trailing twelve months.

FDA records show no clearances under product code NZT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NZT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260