Cleared Traditional

K803157 - AUTO-MATE CAMERA

K803157 is an FDA 510(k) clearance for AUTO-MATE CAMERA, manufactured by Aptek , Ltd.. The device is a Class 2 Radiology device with product code IYO cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K803157 · Aptek , Ltd. · Radiology device
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Feb 1981
Decision
60d
Days
Class 2
Risk

K803157 is an FDA 510(k) clearance for the AUTO-MATE CAMERA. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Aptek , Ltd. (Mchenry, US). The FDA issued a Cleared decision on February 2, 1981 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - 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 Aptek , Ltd. devices

FDA 510(k) Submission Details - K803157

510(k) Number K803157 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1980
Decision Date February 02, 1981
Days to Decision 60 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 107d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYO Device Classification - Class 2, Special Controls

Product Code IYO System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
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 - IYO System, Imaging, Pulsed Echo, Ultrasonic

All 670
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K803157.
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