Cleared Traditional

K895730 - X-RAY EQUIPMENT (VARIOUS TYPES)

K895730 is an FDA 510(k) clearance for X-RAY EQUIPMENT (VARIOUS TYPES), manufactured by Continental X-Ray Corp.. The device is a Class 2 Radiology device with product code JAA cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K895730 · Continental X-Ray Corp. · Radiology device
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Nov 1989
Decision
45d
Days
Class 2
Risk

K895730 is an FDA 510(k) clearance for the X-RAY EQUIPMENT (VARIOUS TYPES). Classified as System, X-ray, Fluoroscopic, Image-intensified (product code JAA), Class II - Special Controls.

Submitted by Continental X-Ray Corp. (Chicago, US). The FDA issued a Cleared decision on November 6, 1989 after a review of 45 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 Continental X-Ray Corp. devices

FDA 510(k) Submission Details - K895730

510(k) Number K895730 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 1989
Decision Date November 06, 1989
Days to Decision 45 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 107d · This submission: 45d
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 K895730.
DIGIFORMER HR DFP-50A
K901405 · Toshiba America Medical Systems, In.C · May 1990
HYDRA VIEW IMAGING SYSTEM
K901323 · Mallinckrodt Group, Inc. · Apr 1990
MOBILE X-RAY TELEVISION UNIT WHA-10A/B
K895394 · Shimadzu Corp. · Nov 1989
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