Cleared Traditional

Faxitron Bioptics Speciemen Radiography System (K170786) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K170786 · Faxitron Bioptics, LLC · Radiology device
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Jul 2017
Decision
124d
Days
Class 2
Risk

K170786 is an FDA 510(k) clearance for the Faxitron Bioptics Speciemen Radiography System. Classified as Cabinet, X-ray System (product code MWP), Class II - Special Controls.

Submitted by Faxitron Bioptics, LLC (Tucson, US). The FDA issued a Cleared decision on July 18, 2017 after a review of 124 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - 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 Faxitron Bioptics, LLC devices

Submission Details

510(k) Number K170786 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2017
Decision Date July 18, 2017
Days to Decision 124 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
17d slower than avg
Panel avg: 107d · This submission: 124d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MWP Cabinet, X-ray System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
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 - MWP Cabinet, X-ray System

All 26
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