Cleared Traditional

K863856 - S-RAY CAMERA

K863856 is an FDA 510(k) clearance for S-RAY CAMERA, manufactured by Uni-Quatro Industries. The device is a Class 2 Radiology device with product code LMC cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K863856 · Uni-Quatro Industries · Radiology device
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Oct 1986
Decision
12d
Days
Class 2
Risk

K863856 is an FDA 510(k) clearance for the S-RAY CAMERA. Classified as Camera, Multi Format, Radiological (product code LMC), Class II - Special Controls.

Submitted by Uni-Quatro Industries (Canada, CA). The FDA issued a Cleared decision on October 14, 1986 after a review of 12 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2040 - 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 Uni-Quatro Industries devices

FDA 510(k) Submission Details - K863856

510(k) Number K863856 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1986
Decision Date October 14, 1986
Days to Decision 12 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 107d · This submission: 12d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LMC Device Classification - Class 2, Special Controls

Product Code LMC Camera, Multi Format, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2040
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 - LMC Camera, Multi Format, Radiological

All 78
Devices cleared under the same product code (LMC) and FDA review panel - the closest regulatory comparables to K863856.
FTI 200 MEDICAL THERMAL IMAGER
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DIGISPOT IMAGER
K871778 · Siemens Gammasonics, Inc. · May 1987
KODAK EKTASCAN LASER PRINTER, MODEL 100
K863629 · Eastman Kodak Company · Oct 1986
KODAK EKTASCAN VIDEO CAMERA & COMPACT VIDEO CAMERA
K860691 · Eastman Kodak Company · Mar 1986
3M DRY SILVER IMAGER
K855043 · 3M Company · Jan 1986
3M LASER IMAGER
K843502 · 3M Company · Nov 1984