Cleared Traditional

K896708 - PERLINK CASSETTE, KIRAN CASSETTE

K896708 is an FDA 510(k) clearance for PERLINK CASSETTE, manufactured by Perlink USA, Inc.. The device is a Class 2 Radiology device with product code IXA cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K896708 · Perlink USA, Inc. · Radiology device
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May 1990
Decision
160d
Days
Class 2
Risk

K896708 is an FDA 510(k) clearance for the PERLINK CASSETTE, KIRAN CASSETTE. Classified as Cassette, Radiographic Film (product code IXA), Class II - Special Controls.

Submitted by Perlink USA, Inc. (Rye, US). The FDA issued a Cleared decision on May 7, 1990 after a review of 160 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1850 - 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 - K896708

510(k) Number K896708 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1989
Decision Date May 07, 1990
Days to Decision 160 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d slower than avg
Panel avg: 107d · This submission: 160d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IXA Device Classification - Class 2, Special Controls

Product Code IXA Cassette, Radiographic Film
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1850
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 - IXA Cassette, Radiographic Film

All 36
Devices cleared under the same product code (IXA) and FDA review panel - the closest regulatory comparables to K896708.
DU PONT MV DARKROOM CASSETTE
K931074 · E.I. Dupont DE Nemours & Co., Inc. · Jun 1993
MILNE-CHARKOT SHOTT-THUR CASSETTE HOLDER
K923334 · Cook, Inc. · Jan 1993
KODAK INSIGHT PORTABLE IMAGING SYSTEM
K921826 · Eastman Kodak Company · Aug 1992
DU PONT MAMMOGRAPHY CASSETTE
K900620 · E.I. Dupont DE Nemours & Co., Inc. · Feb 1990
CRONEX COMPACT MAMMOGRAPHY CASSETTE
K895335 · E.I. Dupont DE Nemours & Co., Inc. · Feb 1990
KODAK X-OMATIC RA CASSETTE
K890750 · Eastman Kodak Company · Mar 1989