Cleared Special

K060566 - MINXRAY, MODELS HFP24 AND HFP40

K060566 is an FDA 510(k) clearance for MINXRAY, manufactured by Mikasa X-Ray Co., Ltd.. The device is a Class 2 Radiology device with product code IZL cleared through the Special 510(k) pathway after a 33-day FDA review.

K060566 · Mikasa X-Ray Co., Ltd. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2006
Decision
33d
Days
Class 2
Risk

K060566 is an FDA 510(k) clearance for the MINXRAY, MODELS HFP24 AND HFP40. Classified as System, X-ray, Mobile (product code IZL), Class II - Special Controls.

Submitted by Mikasa X-Ray Co., Ltd. (Deer Field, US). The FDA issued a Cleared decision on April 5, 2006 after a review of 33 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1720 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K060566

510(k) Number K060566 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2006
Decision Date April 05, 2006
Days to Decision 33 days
Submission Type Special
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
74d faster than avg
Panel avg: 107d · This submission: 33d
Pathway characteristics
Modification to existing cleared device.

IZL Device Classification - Class 2, Special Controls

Product Code IZL System, X-ray, Mobile
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1720
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 - IZL System, X-ray, Mobile

All 215
Devices cleared under the same product code (IZL) and FDA review panel - the closest regulatory comparables to K060566.
AMX4-50 AND AMX4-31 MOBILE DIGITAL DIAGNOSTIC RADIOGRAPHIC SYSTEMS
K063262 · Virtual Imaging · Dec 2006
OPTIONAL REMOTE CONTROL, MODEL RC-115, FOR PORTABLE X-RAY SYSTEM, MODEL SR-115
K062472 · Source-Ray, Inc. · Oct 2006
PULSERA
K061685 · Philips Medical Systems North America Co. · Sep 2006
GE DEFINIUM AMX 700, MODEL AMX 700
K052897 · General Electric Medical Systems · Nov 2005
MINXRAY, MODEL HF100H+
K052721 · Minxray, Inc. · Oct 2005
AJEX 9015/135H PORTABLE X-RAY
K052341 · Jpi America, Inc. · Oct 2005
K060566 · MINXRAY, MODELS HFP24 AND HFP40
Download PDF FDA Summary Mikasa X-Ray Co., Ltd.