# K020150: CRC-15BT

- Pathway: 510(k) (Traditional)
- Applicant: Capintec, Inc.
- Decided: Aug 2, 2002 after 198 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.
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) Capintec CRC 15R dose calibrator: named in the summary without a submission number

## Indications for use
The CRC 15BT dose calibrator is intended to be used by trained medical physicists, or qualified technologists to measure the activity or output of radioactive brachytherapy sources, including HDR, LDR and IVBT sources.

Source page: https://510kreport.com/device/K020150
Methodology: https://510kreport.com/methodology