Cleared Traditional

K960198 - DIGISCOPE RX-2

K960198 is an FDA 510(k) clearance for DIGISCOPE RX-2, manufactured by Medirex, Inc.. The device is a Class 2 Radiology device with product code OXO cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K960198 · Medirex, Inc. · Radiology device
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Mar 1996
Decision
56d
Days
Class 2
Risk

K960198 is an FDA 510(k) clearance for the DIGISCOPE RX-2. Classified as Image-intensified Fluoroscopic X-ray System, Mobile (product code OXO), Class II - Special Controls.

Submitted by Medirex, Inc. (Newtown, US). The FDA issued a Cleared decision on March 12, 1996 after a review of 56 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medirex, Inc. devices

FDA 510(k) Submission Details - K960198

510(k) Number K960198 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1996
Decision Date March 12, 1996
Days to Decision 56 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
51d faster than avg
Panel avg: 107d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OXO Device Classification - Class 2, Special Controls

Product Code OXO Image-intensified Fluoroscopic X-ray System, Mobile
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
Definition Fluoroscopy Of The Human Body.
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 - OXO Image-intensified Fluoroscopic X-ray System, Mobile

All 40
Devices cleared under the same product code (OXO) and FDA review panel - the closest regulatory comparables to K960198.
DIGISCOPE RX-2 (9 OPTION)
K965013 · Medirex, Inc. · Jan 1997
SIREMOBIL COMPACT
K963093 · Siemens Medical Solutions USA, Inc. · Sep 1996
ORCA
K960907 · Lunar Corp. · May 1996
PHILIPS BV 300 SERIES
K953910 · Philips Medical Systems North America, Inc. · Oct 1995
SHIMADZU MOBILE X-RAY SYSTEMS
K940294 · Shimadzu Precision Instruments, Inc. · Mar 1994
STENOSCOP MOBILE FLUOROSCOPIC XRAY SYSTEM
K933447 · GE Medical Systems · Aug 1993