Cleared Traditional

K983918 - RADIOLUCENT CASSETTE LIMB POSITIONER (R-CLIP)

K983918 is an FDA 510(k) clearance for RADIOLUCENT CASSETTE LIMB POSITIONER (R..., manufactured by Mastek, Inc.. The device is a Class 2 Radiology device with product code IXA cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K983918 · Mastek, Inc. · Radiology device
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Mar 1999
Decision
128d
Days
Class 2
Risk

K983918 is an FDA 510(k) clearance for the RADIOLUCENT CASSETTE LIMB POSITIONER (R-CLIP). Classified as Cassette, Radiographic Film (product code IXA), Class II - Special Controls.

Submitted by Mastek, Inc. (Houston, US). The FDA issued a Cleared decision on March 12, 1999 after a review of 128 days - within the typical 510(k) review window.

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 Mastek, Inc. devices

FDA 510(k) Submission Details - K983918

510(k) Number K983918 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1998
Decision Date March 12, 1999
Days to Decision 128 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 107d · This submission: 128d
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 32
Devices cleared under the same product code (IXA) and FDA review panel - the closest regulatory comparables to K983918.
AGFA MAMORAY MAMMOGRAPHIC CASSETTE, AGFA METAL-BODIED CAWO CASSETTE, AGFA CURIX AND LIGHTWEIGHT CASSETTE
K023020 · Agfa Corp. · Sep 2002
KODAK X-OMAT CASSETTE/LEADLESS FOR DENTAL USE
K021903 · Eastman Kodak Company · Jul 2002
KODAK DIRECTVIEW TABLETOP CASSETTE
K013686 · Eastman Kodak Company · Dec 2001
TRIMAX RADIOGRAPHIC CASSETTE
K980722 · Imation Corp. · Mar 1998
UMI X-RAY FILM CASSETTE
K971431 · Umi Intl. · May 1997
SOLO-SLED
K970090 · Solo-Sled, LLC · Apr 1997