# K101452: Capintec CRC 55T Series Dose Calibrators, Models CRC 55TR, CRC 55TPET and CRC 55TW

- Pathway: 510(k) (Special)
- Applicant: Capintec, Inc.
- Decided: Aug 9, 2010 after 76 days
- Product code: KPT (Calibrator, Dose, Radionuclide)
- Device class: 2
- Regulation: 21 CFR 892.1360
- Recalls of this device: none
- 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 25 series: named in the summary without a submission number

## Most influential descendants
- K162394: CRC-77tHR (2017), 0 descendants of its own

## Indications for use
The CRC 55t series, which includes the standard S5tR dose calibrator, reduced pressure chamber (CRC S5tPET) and well counter (CRC55tW), is intended to be used by qualified nuclear medicine technologists, nuclear medicine physicians, and radiopharmacists to measure a wide range of radiopharmaceuticals and radioactive materials, including high energy beta and gamma emitters for diagnostic, therapeutic, or in vitro laboratory tests. It is also designed for use by trained medical physicists to measure the output of most radioactive brachytherapy sources, including LDR, HDR, 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 in vitro laboratory test applications. This device is also used in numerous research applications for measurement of radioactive materials.

Source page: https://510kreport.com/device/K101452
Methodology: https://510kreport.com/methodology