# K030066: Cal/Rad Mark VI/VDC-505 Dose Calibrator, Model 34-165

- Pathway: 510(k) (Traditional)
- Applicant: Nuclear Associates
- Decided: Aug 29, 2003 after 234 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices 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.

## Most influential descendants
- K142325: Veenstra Instruments VDC-506 Dose Calibrator (2014), 0 descendants of its own
- K080297: Medrad Intego Pet Infusion System (2008), 0 descendants of its own

## Indications for use
The Mark VI 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 radiopharmaceuticaIs 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 ac$vity prior to patient administration. Data related to the factory calibration is stored in the chamber. This standardizes the response of each ion chamber, allowing each chamber to report the same amount of electric current for the same radiation source. The isotopic calibration factors are stored in the controlheadout unit. The ion chamber current is processed using the isotopic calibration factors stored in the control unit in order to determine the amount of radioactive material present.

Source page: https://510kreport.com/device/K030066
Methodology: https://510kreport.com/methodology