# K042746: Pet-Dose

- Pathway: 510(k) (Traditional)
- Applicant: Comecer S.R.L.
- Decided: Nov 22, 2004 after 49 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
PET-Dose is a radionuclide dose calibrator designed to measure the amount of radioactity in vials, syringes, and in any other user-defined geometry samples. It is intended to assay radiopharmaceuticals before their administration to patients, by measuring the residual of radiopharmaceutical in vials, the activity of the injectable in syringes, the activity of capsules before they are administered to patients, etc. The best applications of PET-Dose are activity measurements of beta~ emitters used in PET diagnostics such as: ' 8F, 13N, 150, etc. PET-Dose is best fitted for use in nuclear medicine departments and, particularly, in PET centers. The PET-Dose is intended to be used by trained medical physicist or qualified experts or nuclear medicine technicians to perform activity measurements in the nuclear medicine departments and, particularly, in PET centers.

Source page: https://510kreport.com/device/K042746
Methodology: https://510kreport.com/methodology