510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K042746Substantially Equivalent

Pet-Dose

Comecer S.r.l., Crofton MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K042746 is the FDA 510(k) clearance record for PET-DOSE, a class II device, cleared for Comecer S.R.L. on under FDA product code KPT (Calibrator, Dose, Radionuclide). FDA records list one 510(k) clearance for Comecer S.R.L. As of , FDA records show no recalls naming K042746.

Clearance record

Decision date
Received
(49 days to decision)
Product code
KPT Calibrator, Dose, Radionuclide
Regulation
21 CFR 892.1360
Device class
Class II
Review panel
Radiology
Applicant
Comecer S.R.L. P.O. Box 4341, Crofton MD
510(k) summary
Statement
Third party review
Yes

Clearances, product code KPT

Trailing 12 months

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

FDA records show no clearances under product code KPT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KPT, 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