Cleared Traditional

K914446 - UROVIEW 2000

K914446 is an FDA 510(k) clearance for UROVIEW 2000, manufactured by Oec-Diasonics, Inc.. The device is a Class 2 Radiology device with product code JAA cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K914446 · Oec-Diasonics, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1992
Decision
98d
Days
Class 2
Risk

K914446 is an FDA 510(k) clearance for the UROVIEW 2000, MODIFICATION. Classified as System, X-ray, Fluoroscopic, Image-intensified (product code JAA), Class II - Special Controls.

Submitted by Oec-Diasonics, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on January 10, 1992 after a review of 98 days - within the typical 510(k) review window.

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.

View all Oec-Diasonics, Inc. devices

FDA 510(k) Submission Details - K914446

510(k) Number K914446 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1991
Decision Date January 10, 1992
Days to Decision 98 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 107d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAA Device Classification - Class 2, Special Controls

Product Code JAA System, X-ray, Fluoroscopic, Image-intensified
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
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 - JAA System, X-ray, Fluoroscopic, Image-intensified

All 143
Devices cleared under the same product code (JAA) and FDA review panel - the closest regulatory comparables to K914446.
DIGITAL RADIOGRAPHY SYSTEM IDR-1000
K920720 · Shimadzu Medical Systems · Apr 1992
DIGITAL RADIOGRAPHY SYSTEM IDR-2000
K920721 · Shimadzu Medical Systems · Apr 1992
PEGASUS LATERAL CARDIAC POSITIONER
K915592 · Fischer Imaging Corp. · Jan 1992
FVP-1000 FAMILY AND FVP-1000D FAMILY
K905694 · Fischer Imaging Corp. · Nov 1991
FLUROSPOT H VERSION 2
K914525 · Siemens Medical Solutions USA, Inc. · Nov 1991
PHILIPS DIAGNOST 96
K912470 · Philips Medical Systems, Inc. · Aug 1991