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PET-Dose Radionuclide Dose Calibrator KPT

by Comecer S.R.L.

510(k) K042746

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 5 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 5 Oct 2026. What this means

Regulatory status

as of registry sync 5 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK042746 Date22 Nov 2004ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 5 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Pet-Dose
510(k) Number
FDA Product Code
KPT
Device Class
Class II
Regulation
21 CFR Part 892.1360
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The PET-Dose is a Radionuclide Dose Calibrator, a Class II medical device designed to measure radioactivity in radionuclide samples. It falls under the FDA’s product code KPT and is classified under the Radiology specialty. This device quantifies administered doses of radiopharmaceuticals, ensuring accurate administration in positron emission tomography (PET) procedures and other nuclear medicine applications. Its primary function is to verify dose accuracy for user-defined geometries, including syringe samples.

The PET-Dose is supplied as a reusable device and is intended for use in radiology settings, including nuclear medicine departments. It operates under standard environmental conditions and does not require sterile packaging. The device is FDA-cleared through a Traditional 510(k) pathway, with clearance granted on November 22, 2004, following a 49-day review by the Radiology (RA) Advisory Committee. No specific MRI safety classification is stated in the regulatory records.

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the PET-Dose Radionuclide Dose Calibrator used for?

    The PET-Dose is designed to measure radioactivity in radionuclide samples, specifically quantifying administered doses of radiopharmaceuticals. This ensures accurate dose administration during positron emission tomography (PET) procedures and other nuclear medicine applications, including verifying dose accuracy for user-defined geometries like syringe samples.

  • Is the PET-Dose a single-use or reusable device?

    The PET-Dose is supplied as a reusable device, intended for long-term use in radiology settings such as nuclear medicine departments. It operates under standard environmental conditions and does not require sterile packaging for each use.

  • What regulatory pathway was followed for the PET-Dose?

    The PET-Dose received FDA clearance through a Traditional 510(k) pathway, classified as substantially equivalent to a predicate device. The review was conducted by the Radiology (RA) Advisory Committee and took 49 days, with clearance granted on November 22, 2004.

  • Does the PET-Dose require sterile packaging?

    No, the PET-Dose does not require sterile packaging. It is designed for reusable use in controlled radiology environments, including nuclear medicine departments, where standard environmental conditions apply.

  • What types of samples can the PET-Dose measure?

    The PET-Dose is capable of measuring radioactivity in radionuclide samples with user-defined geometries, particularly syringe samples. This ensures precise dose verification for clinical applications in PET imaging and nuclear medicine.