Cleared Traditional

K904005 - HUESTIS FLEXI-BOARD

K904005 is an FDA 510(k) clearance for HUESTIS FLEXI-BOARD, manufactured by Huestis Machine Corp.. The device is a Class 2 Radiology device with product code JAD cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K904005 · Huestis Machine Corp. · Radiology device
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Nov 1990
Decision
92d
Days
Class 2
Risk

K904005 is an FDA 510(k) clearance for the HUESTIS FLEXI-BOARD. Classified as System, Therapeutic, X-ray (product code JAD), Class II - Special Controls.

Submitted by Huestis Machine Corp. (Bristol, US). The FDA issued a Cleared decision on November 29, 1990 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5900 - 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 Huestis Machine Corp. devices

FDA 510(k) Submission Details - K904005

510(k) Number K904005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1990
Decision Date November 29, 1990
Days to Decision 92 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 107d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAD Device Classification - Class 2, Special Controls

Product Code JAD System, Therapeutic, X-ray
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5900
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 - JAD System, Therapeutic, X-ray

All 41
Devices cleared under the same product code (JAD) and FDA review panel - the closest regulatory comparables to K904005.
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K882484 · Computerized Medical Systems, Inc. · Dec 1988
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K844424 · Varian Assoc., Inc. · Feb 1985