Cleared Traditional

K081557 - PORTABLE SUPINE PATIENT SUPPORT AND CASSETTE HOLDER

K081557 is an FDA 510(k) clearance for PORTABLE SUPINE PATIENT SUPPORT AND CAS..., manufactured by Jddb Manufacturing, Inc.. The device is a Class 2 Radiology device with product code IXA cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K081557 · Jddb Manufacturing, Inc. · Radiology device
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Sep 2008
Decision
99d
Days
Class 2
Risk

K081557 is an FDA 510(k) clearance for the PORTABLE SUPINE PATIENT SUPPORT AND CASSETTE HOLDER. Classified as Cassette, Radiographic Film (product code IXA), Class II - Special Controls.

Submitted by Jddb Manufacturing, Inc. (Riverdale, US). The FDA issued a Cleared decision on September 10, 2008 after a review of 99 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 Jddb Manufacturing, Inc. devices

FDA 510(k) Submission Details - K081557

510(k) Number K081557 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2008
Decision Date September 10, 2008
Days to Decision 99 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 107d · This submission: 99d
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 33
Devices cleared under the same product code (IXA) and FDA review panel - the closest regulatory comparables to K081557.
DS CASSETTE
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