Cleared Traditional

K810072 - 105MM ROLL FILM FLUOROGR. CAMERA, #105

K810072 is an FDA 510(k) clearance for 105MM ROLL FILM FLUOROGR. CAMERA, manufactured by Scientex Corp.. The device is a Class 2 Radiology device with product code IZJ cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K810072 · Scientex Corp. · Radiology device
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Feb 1981
Decision
30d
Days
Class 2
Risk

K810072 is an FDA 510(k) clearance for the 105MM ROLL FILM FLUOROGR. CAMERA, #105. Classified as Camera, X-ray, Fluorographic, Cine Or Spot (product code IZJ), Class II - Special Controls.

Submitted by Scientex Corp. (Mchenry, US). The FDA issued a Cleared decision on February 12, 1981 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1620 - 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 Scientex Corp. devices

FDA 510(k) Submission Details - K810072

510(k) Number K810072 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1981
Decision Date February 12, 1981
Days to Decision 30 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 107d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IZJ Device Classification - Class 2, Special Controls

Product Code IZJ Camera, X-ray, Fluorographic, Cine Or Spot
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1620
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.