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CAL-3 Calibrated Radioactivity Assayer

by Dosimeter Corp. 510(k)

Active United States

510(k) K811320

Overview

The CAL-3 Calibrated Radioactivity Assayer is a Class II medical device used in radiology for calibrating radioactivity measurements. It is designed to provide accurate calibration for dosimeters and radionuclide measurements in medical applications.

The device is manufactured by Dosimeter Corp. and received FDA 510(k) clearance on June 2, 1981. It is supplied as a calibrated assayer and is intended for use in radiology settings. The device is not specified as single-use or reusable, and no information regarding sterility, MRI safety, or storage conditions is provided.

AI-generated from registry data, 23 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK811320 Date2 Jun 1981ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

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