Cleared Traditional

K893475 - UROVIEW II

K893475 is an FDA 510(k) clearance for UROVIEW II, 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.

K893475 · Oec-Diasonics, Inc. · Radiology device
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Aug 1989
Decision
98d
Days
Class 2
Risk

K893475 is an FDA 510(k) clearance for the UROVIEW II. 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 August 10, 1989 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 - K893475

510(k) Number K893475 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1989
Decision Date August 10, 1989
Days to Decision 98 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
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 K893475.
MOBILE X-RAY TELEVISION UNIT WHA-10A/B
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X-RAY EQUIPMENT (VARIOUS TYPES)
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DA-100HS
K894913 · Fischer Imaging Corp. · Sep 1989
DIGITAL SPOT IMAGING (DSI)
K893131 · Philips Medical Systems, Inc. · Jun 1989
UNIVERSAL ABC CONTROLER
K883580 · Philips Medical Systems (Cleveland), Inc. · Jan 1989
MEDRAD FLUOROSCOPIC VIDEO ENHANCEMENT SYSTEM
K884317 · Medrad, Inc. · Dec 1988