Cleared Traditional

K081073 - HDR VISION, VISION HDR, HD R/F, UROMAT HD R/F

K081073 is an FDA 510(k) clearance for HDR VISION, manufactured by Pausch, LLC. The device is a Class 2 Radiology device with product code OWB cleared through the Traditional 510(k) pathway after a 234-day FDA review.

K081073 · Pausch, LLC · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2008
Decision
234d
Days
Class 2
Risk

K081073 is an FDA 510(k) clearance for the HDR VISION, VISION HDR, HD R/F, UROMAT HD R/F. Classified as Interventional Fluoroscopic X-ray System (product code OWB), Class II - Special Controls.

Submitted by Pausch, LLC (Tenton Falls, US). The FDA issued a Cleared decision on December 5, 2008 after a review of 234 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1650 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K081073

510(k) Number K081073 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 2008
Decision Date December 05, 2008
Days to Decision 234 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
127d slower than avg
Panel avg: 107d · This submission: 234d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OWB Device Classification - Class 2, Special Controls

Product Code OWB Interventional Fluoroscopic X-ray System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
Definition Interventional Fluoroscopy
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - OWB Interventional Fluoroscopic X-ray System

All 324
Devices cleared under the same product code (OWB) and FDA review panel - the closest regulatory comparables to K081073.
OEC 9900 ELITE
K082781 · Ge Healthcare Surgery · May 2009
VERADIUS, MODEL 718-130
K090590 · Philips Medical Systems North America Co. · Mar 2009
RADPRO ION
K083725 · Virtual Imaging, Inc. · Jan 2009
PRECISION RXI ANALOG AND DIGITAL X-RAY SYSTEMS
K082243 · General Medical Merate S.P.A · Nov 2008
RFVISION, MODEL 9.9D
K080847 · Almana Medical Imaging · Aug 2008
OEC 9900 ELITE
K073543 · Ge Oec Medical Systems · May 2008
K081073 · HDR VISION, VISION HDR, HD R/F, UROMAT HD R/F
Download PDF FDA Summary Pausch, LLC