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Radcal Model 4050 Radionuclide Calib

by Radcal Corp.

510(k) K841787

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK841787 Date16 Jul 1984ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

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 RADCAL MODEL 4050 RADIONUCLIDE CALIB is a Class II medical device designed for calibrating radionuclide measurements in radiology. It is intended for use in medical settings to ensure accurate dosimetry and radiation detection.

This device is supplied as a single-use calibration tool and is regulated under FDA 510(k) clearance (K841787). It operates in radiology environments and is not MRI-safe. Proper storage and handling are required to maintain its functionality.

Other devices from Radcal Corp.

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 RADCAL Model 4050 Radionuclide Calibrator used for?

    This device is a single-use calibration tool designed to ensure accurate dosimetry and radiation detection in radiology environments.

  • Is the RADCAL Model 4050 Radionuclide Calibrator reusable?

    No, the device is supplied as a single-use calibration tool and is intended for one-time use to maintain its functionality and accuracy.

  • Is the RADCAL Model 4050 Radionuclide Calibrator safe to use in an MRI environment?

    No, the device is not MRI-safe and should not be used in an MRI environment.

  • What is the regulatory status of the RADCAL Model 4050 Radionuclide Calibrator?

    The device is regulated under FDA 510(k) clearance (K841787) and is classified as a Class II medical device.