# K974112: Vacudap, Model 2000, 2001

- Pathway: 510(k) (Traditional)
- Applicant: Victoreen, Inc.
- Decided: Jan 29, 1998 after 90 days
- Product code: KPR (System, X-Ray, Stationary)
- Device class: 2
- Regulation: 21 CFR 892.1680
- 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 K941931 (1994). 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)
- K941931: Diagnostic X-Ray Patient Exposure Indicator, Victoreen, Inc. (1994) Summary page 1.

## Indications for use
The Nuclear Associates VacuDAP - Model 2000, 2001 is intended to measure the radiation output of diagnostic X-ray generating machines during imaging of patients in both radiography and fluoroscopy. The instrument measures and displays Dose Area Product, a parameter that can be related to patient dose by a Medical Physicist. The Dose Area Product measurement includes the influence of dose rate, screening time and used field quantity variables. The instrument accumulates Dose Area Product values until manually reset by the user.

Source page: https://510kreport.com/device/K974112
Methodology: https://510kreport.com/methodology