# K142325: Veenstra Instruments VDC-506 Dose Calibrator

- Pathway: 510(k) (Special)
- Applicant: Comecer Netherlands B.V.
- Decided: Sep 18, 2014 after 29 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 K030066 (2003). 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)
- K030066: Cal/Rad Mark VI/VDC-505 Dose Calibrator, Model 34-165, Nuclear Associates (2003) Summary page 4.

## Indications for use
The Veenstra Instruments VDC-506 Dose Calibrator is designed to measure the amount of radioactive material in vials, syringes and capsules. It is used to measure the amount of activity used to prepare radiopharmaceutical kits, measure the activity in syringes of radiopharmaceuticals prior to injection and to quantify the activity remaining in the syringe following injection. It is indicated for use in the preparation of radiopharmaceuticals and verification of the activity prior to patient administration.

Source page: https://510kreport.com/device/K142325
Methodology: https://510kreport.com/methodology