# K141413: CRC PC with Smart Chamber

- Pathway: 510(k) (Special)
- Applicant: Capintec, Inc.
- Decided: Jun 27, 2014 after 29 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 55t series: named in the summary without a submission number

## Most influential descendants
- K192199: CRC PC Smart Chamber K1 (2019), 0 descendants of its own

## Indications for use
The CRC PC Smart Chamber series 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 bela and gamma emitters for diagnostic and therapeutic applications. It is also designed for use by trained medical physicists far diagnostic and therapeutic applications including measurement of the output of most radioactive brachytherapy sources, including LDR, HOR, and IVBT sources. All brachytherapy sources must be measured in the appropriate source holder. This device is also used in numerous research applications for measurement of radioactive materials.

Source page: https://510kreport.com/device/K141413
Methodology: https://510kreport.com/methodology