# K192199: CRC PC Smart Chamber K1

- Pathway: 510(k) (Special)
- Applicant: Capintec, Inc.
- Decided: Sep 12, 2019 after 30 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 K141413 (2014). 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)
- K141413: CRC PC with Smart Chamber, Capintec, Inc. (2014) Summary page 4.

## Indications for use
The CRC PC Smart Chamber K1 is intended to be used by qualified nuclear medicine technologists, nuclear medicine physicians, and radiopharmacists to measure radiopharmaceuticals, including high energy beta and gamma emitters for diagnostic applications. The CRC PC Smart Chamber K1 is intended to be used only with the TEMA Karls 100 radiopharmaceutical dose administration system.

Source page: https://510kreport.com/device/K192199
Methodology: https://510kreport.com/methodology