# K071396: CRC 25 Series (CRC 25R, CRC 25PET, CRC 25W) Dose Calibrators

- Pathway: 510(k) (Special)
- Applicant: Capintec, Inc.
- Decided: Jun 28, 2007 after 38 days
- Product code: KPT (Calibrator, Dose, Radionuclide)
- Device class: 2
- Regulation: 21 CFR 892.1360
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) CRC 15 Ultra: named in the summary without a submission number

## Most influential descendants
- K090296: Atomlab 400 and Atomlab 500 Dose Calibrators, Models 086-330, -331, -332, -335 and -336 (2009), 0 descendants of its own

## Recalls of this device
- Jul 8, 2011 · Not classified · Z-0177-2012: Software error in Rev. 2.01 and Rev 2.02 for Capintec CRC 25PET

## Indications for use
The CRC 25R dose calibrator, which includes optional well counter (CRC 25W) or reduced pressure chamber (CRC 25PET), is intended to be used by qualified nuclear medicine technologists to measure a wide range radiopharmaceuticals, including high energy beta and gamma emitters. It is also designed for use by trained medical physicists to measure the output of most radioactive brachytherapy sources, including HDR, LDR and IVBT sources. All brachytherapy sources must be measured in the appropriate source holder. The well counter is designed for measurement of low activity radioactive sources or solutions, including laboratory test applications. This device is used in numerous research applications for measurement of radioactive materials.

Source page: https://510kreport.com/device/K071396
Methodology: https://510kreport.com/methodology