Cleared Traditional

K101042 - BLADEVIEW (FDA 510(k) Clearance)

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

K101042 · Accogent, LLC · Radiology device
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Oct 2010
Decision
198d
Days
Class 2
Risk

K101042 is an FDA 510(k) clearance for the BLADEVIEW. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Accogent, LLC (Palm Beach, US). The FDA issued a Cleared decision on October 29, 2010 after a review of 198 days - an extended review cycle.

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 Accogent, LLC devices

Submission Details

510(k) Number K101042 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2010
Decision Date October 29, 2010
Days to Decision 198 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
91d slower than avg
Panel avg: 107d · This submission: 198d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code KPR System, X-ray, Stationary
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.

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