Cleared Traditional

K896707 - PERLINK SCREEN, KIRAN SCREEN

K896707 is an FDA 510(k) clearance for PERLINK SCREEN, manufactured by Perlink USA, Inc.. The device is a Class 1 Radiology device with product code EAM cleared through the Traditional 510(k) pathway after a 275-day FDA review.

K896707 · Perlink USA, Inc. · Radiology device
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Aug 1990
Decision
275d
Days
Class 1
Risk

K896707 is an FDA 510(k) clearance for the PERLINK SCREEN, KIRAN SCREEN. Classified as Screen, Intensifying, Radiographic (product code EAM), Class I - General Controls.

Submitted by Perlink USA, Inc. (Rye, US). The FDA issued a Cleared decision on August 30, 1990 after a review of 275 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1960 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Perlink USA, Inc. devices

FDA 510(k) Submission Details - K896707

510(k) Number K896707 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1989
Decision Date August 30, 1990
Days to Decision 275 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
168d slower than avg
Panel avg: 107d · This submission: 275d
Pathway characteristics
Predicate-based equivalence.

EAM Device Classification - Class 1, General Controls

Product Code EAM Screen, Intensifying, Radiographic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1960
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 - EAM Screen, Intensifying, Radiographic

All 30
Devices cleared under the same product code (EAM) and FDA review panel - the closest regulatory comparables to K896707.
ULTRA-VISION RAPID INTENSIFYING SCREEN
K920190 · E.I. Dupont DE Nemours & Co., Inc. · May 1992
ULTRA-VISION DETAIL INTENSIFYING SCREEN
K920200 · E.I. Dupont DE Nemours & Co., Inc. · May 1992
ULTRA-VISION FAST DETAIL INTENSIFYING SCREEN
K920194 · E.I. Dupont DE Nemours & Co., Inc. · May 1992
CRONEX QUANTA RAPID SR397 RARE EARTH INTENS SCREEN
K900448 · E.I. Dupont DE Nemours & Co., Inc. · Feb 1990
CRONEX QUANTA SR300 INTENSIFYING SCREEN
K900103 · E.I. Dupont DE Nemours & Co., Inc. · Feb 1990
CRONEX QUANTA SUPER RAPID SR339 RARE EARTH
K900318 · E.I. Dupont DE Nemours & Co., Inc. · Feb 1990