# K162394: CRC-77tHR

- Pathway: 510(k) (Traditional)
- Applicant: Capintec, Inc.
- Decided: Mar 8, 2017 after 194 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
Longest line of descent: 1 generation back to K101452 (2010). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101452: Capintec CRC 55T Series Dose Calibrators, Models CRC 55TR, CRC 55TPET and CRC 55TW, Capintec, Inc. (2010) Summary page 4.

## Indications for use
The CRC-77tHR is intended to be used by qualified radiopharmacists, radiochemists, radiation physicists, or other appropriately trained personnel in isotope production sites to measure a wide range of measure a wide range of high activity radiopharmaceuticals and radioactive materials, including high energy beta and gamma emitters. The device is not intended for use with brachytherapy sources. This device is also used in numerous research applications for measurement of high activity levels of radioactive materials.

Source page: https://510kreport.com/device/K162394
Methodology: https://510kreport.com/methodology