Cleared Traditional

K070634 - SOYEE PORTABLE X-RAY UNIT, MODEL SY-HF-110

K070634 is an FDA 510(k) clearance for SOYEE PORTABLE X-RAY UNIT, manufactured by Soyee Product, Inc.. The device is a Class 2 Radiology device with product code IZL cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K070634 · Soyee Product, Inc. · Radiology device
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Jul 2007
Decision
126d
Days
Class 2
Risk

K070634 is an FDA 510(k) clearance for the SOYEE PORTABLE X-RAY UNIT, MODEL SY-HF-110. Classified as System, X-ray, Mobile (product code IZL), Class II - Special Controls.

Submitted by Soyee Product, Inc. (Sound Beach, US). The FDA issued a Cleared decision on July 11, 2007 after a review of 126 days - within the typical 510(k) review window.

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: 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 Soyee Product, Inc. devices

FDA 510(k) Submission Details - K070634

510(k) Number K070634 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2007
Decision Date July 11, 2007
Days to Decision 126 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
19d slower than avg
Panel avg: 107d · This submission: 126d
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 156
Devices cleared under the same product code (IZL) and FDA review panel - the closest regulatory comparables to K070634.
SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTION
K080701 · Shimadzu Corp. · May 2008
FCR GO PORTABLE DIGITAL X-RAY SYSTEM
K080945 · Fujifilm Medical Systems U.S.A, Inc. · Apr 2008
OPDIMA DIGITAL MAMMOGRAPHIC X-RAY SYSTEM
K072392 · Siemens Medical Solutions USA, Inc. · Sep 2007
OPDIMA DIGITAL MAMMOGRAPHIC X-RAY SYSTEM
K071015 · Siemens Medical Solutions USA, Inc. · May 2007
PULSERA
K061685 · Philips Medical Systems North America Co. · Sep 2006
MINXRAY, MODEL HF100H+
K052721 · Minxray, Inc. · Oct 2005