Cleared Traditional

K882519 - X-RAY MARKER

K882519 is an FDA 510(k) clearance for X-RAY MARKER, manufactured by Karlin Technology, Inc.. The device is a Class 1 Radiology device with product code JAC cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K882519 · Karlin Technology, Inc. · Radiology device
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Aug 1988
Decision
53d
Days
Class 1
Risk

K882519 is an FDA 510(k) clearance for the X-RAY MARKER. Classified as System, X-ray, Film Marking, Radiographic (product code JAC), Class I - General Controls.

Submitted by Karlin Technology, Inc. (Marina Del Rey, US). The FDA issued a Cleared decision on August 9, 1988 after a review of 53 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1640 - 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 Karlin Technology, Inc. devices

FDA 510(k) Submission Details - K882519

510(k) Number K882519 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1988
Decision Date August 09, 1988
Days to Decision 53 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
54d faster than avg
Panel avg: 107d · This submission: 53d
Pathway characteristics
Predicate-based equivalence.

JAC Device Classification - Class 1, General Controls

Product Code JAC System, X-ray, Film Marking, Radiographic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1640
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 - JAC System, X-ray, Film Marking, Radiographic

All 9
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