Cleared Traditional

K851440 - RDIOGRAPHIC WALL HOLDER OR FILM RECEPTOR

K851440 is an FDA 510(k) clearance for RDIOGRAPHIC WALL HOLDER OR FILM RECEPTOR, manufactured by Summit Industries, Inc.. The device is a Class 1 Radiology device with product code IXY cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K851440 · Summit Industries, Inc. · Radiology device
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Jun 1985
Decision
56d
Days
Class 1
Risk

K851440 is an FDA 510(k) clearance for the RDIOGRAPHIC WALL HOLDER OR FILM RECEPTOR. Classified as Holder, Radiographic Cassette, Wall-mounted (product code IXY), Class I - General Controls.

Submitted by Summit Industries, Inc. (Chicago, US). The FDA issued a Cleared decision on June 5, 1985 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1880 - 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 Summit Industries, Inc. devices

FDA 510(k) Submission Details - K851440

510(k) Number K851440 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1985
Decision Date June 05, 1985
Days to Decision 56 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
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.

IXY Device Classification - Class 1, General Controls

Product Code IXY Holder, Radiographic Cassette, Wall-mounted
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1880
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - IXY Holder, Radiographic Cassette, Wall-mounted

All 7
Devices cleared under the same product code (IXY) and FDA review panel - the closest regulatory comparables to K851440.
WALL BUCKY HOLDERS LT. & RT. HAND, & CENTER MOUNT
K925934 · Continental X-Ray Corp. · Mar 1993
BASICAM S COUNTER BALANCE CAMERA
K860454 · Siemens Gammasonics, Inc. · Feb 1986
DYNAMIC CARDIAC PHANTOM 74-347
K853756 · Victoreen, Inc. · Oct 1985
MULTI-SIZE CASSETTE HOLDER
K850125 · Philips Medical Systems (Cleveland), Inc. · Mar 1985
WALL CASSETTE HOLDER - TRAC44
K810194 · Philips Medical Systems (Cleveland), Inc. · Feb 1981