Cleared Traditional

K091255 - MINXRAY, MODEL: BPD60

K091255 is an FDA 510(k) clearance for MINXRAY, manufactured by Minxray, Inc.. The device is a Class 2 Radiology device with product code EHD cleared through the Traditional 510(k) pathway after a 378-day FDA review.

K091255 · Minxray, Inc. · Radiology device
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May 2010
Decision
378d
Days
Class 2
Risk

K091255 is an FDA 510(k) clearance for the MINXRAY, MODEL: BPD60. Classified as Unit, X-ray, Extraoral With Timer (product code EHD), Class II - Special Controls.

Submitted by Minxray, Inc. (Deerfield, US). The FDA issued a Cleared decision on May 12, 2010 after a review of 378 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 872.1800 - 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. Elevated predicate reliance profile. 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 Minxray, Inc. devices

FDA 510(k) Submission Details - K091255

510(k) Number K091255 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 2009
Decision Date May 12, 2010
Days to Decision 378 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
271d slower than avg
Panel avg: 107d · This submission: 378d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EHD Device Classification - Class 2, Special Controls

Product Code EHD Unit, X-ray, Extraoral With Timer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.1800
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 - EHD Unit, X-ray, Extraoral With Timer

All 163
Devices cleared under the same product code (EHD) and FDA review panel - the closest regulatory comparables to K091255.
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K092103 · VATECH Co., Ltd. · Oct 2009