# K081073: HDR Vision, Vision HDR, HD R/F, Uromat HD R/F

- Pathway: 510(k) (Traditional)
- Applicant: Pausch, LLC
- Decided: Dec 5, 2008 after 234 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K801623 (1980). 56 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 58 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062623: Axiom Luminos DRF, Siemens Medical Solutions USA, Inc. (2007) Summary page 1.

## Most influential descendants
- K101042: Bladeview (2010), 0 descendants of its own

## Indications for use
The HDR Vision is intended to be used as a uiversal diagnostic imaging system for rediographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general RIF, angiography and pediatric examinations. The system has medical applications ranging from but not limited to gastrointestinal examinations, cranial, skeletal, thoracic and lung exposures as well as examination of the urogenital tract. They may also be used in lymphography, endoscopy, myelography, venography, pediatrics, arthrography, interventional radiology, digital angiography and digital subtraction angiography. HDR Vision may be used for outpatient and emergency treatment, as well as for mobile transport (wheelchair and bed) The HDR Vision is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image.

Source page: https://510kreport.com/device/K081073
Methodology: https://510kreport.com/methodology