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Crc 25 Series (Crc 25R, Crc 25PET, Crc 25W) Dose Calibrators

by Capintec, Inc.

510(k) K071396

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK071396 Date28 Jun 2007ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0177-2012 FDA Unclassified (pre-2012) initiated 8 Jul 2011

    Software error in Rev. 2.01 and Rev 2.02 for Capintec CRC 25PET

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  • Withdrawn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

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