Cleared Traditional

K945707 - MINXRAY HF80H HIGH FREQUENCY DIAGNOSTIC...

K945707 is an FDA 510(k) clearance for MINXRAY HF80H HIGH FREQUENCY DIAGNOSTIC..., manufactured by Minxray, Inc.. The device is a Class 2 Radiology device with product code IZL cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K945707 · Minxray, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1995
Decision
59d
Days
Class 2
Risk

K945707 is an FDA 510(k) clearance for the MINXRAY HF80H HIGH FREQUENCY DIAGNOSTIC X-RAY UNIT. Classified as System, X-ray, Mobile (product code IZL), Class II - Special Controls.

Submitted by Minxray, Inc. (Northbrook, US). The FDA issued a Cleared decision on January 19, 1995 after a review of 59 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Minxray, Inc. devices

FDA 510(k) Submission Details - K945707

510(k) Number K945707 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1994
Decision Date January 19, 1995
Days to Decision 59 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 107d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 133
Devices cleared under the same product code (IZL) and FDA review panel - the closest regulatory comparables to K945707.
PORTABLE X-RAY UNITS
K020436 · Sedecal., Sa. · Feb 2002
SHIMADZU MOBILE X-RAY SYSTEM MUX-100 SERIES
K001517 · Shimadzu Corp. · Jun 2000
MOBILE X-RAY SYSTEM
K955036 · Shimadzu Corp. · Dec 1995
MOBILETT PLUS MOBILE X-RAY SYSTEM
K932106 · Siemens Medical Solutions USA, Inc. · Sep 1994
VMX MOBILE X-RAY SYSTEM
K910902 · GE Medical Systems · Sep 1991
MC125L-50 SHIMADZU MOBILE X-RAY SYSTEM
K893637 · Shimadzu Medical Systems · Jul 1989