# K052595: CRC 15ULTRA

- Pathway: 510(k) (Traditional)
- Applicant: Capintec, Inc.
- Decided: Nov 8, 2005 after 48 days
- Product code: JAQ (System, Applicator, Radionuclide, Remote-Controlled)
- Device class: 2
- Regulation: 21 CFR 892.5700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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 35R: named in the summary without a submission number
- (no number) CRC 15R: named in the summary without a submission number
- (no number) Beta Counter: named in the summary without a submission number
- (no number) Caprac R Counter: named in the summary without a submission number

## Indications for use
The CRC 15 Ultra multiple chamber dose calibrator, which includes optional beta counter and well counter, is intended to be used by qualified nuclear medicine technologists to measure a wide range radiophamaceuticals, 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/K052595
Methodology: https://510kreport.com/methodology