Cleared Traditional

EASY MOVING MOBILE X-RAY UNIT (MODEL SM-HF) (K012663) - FDA 510(k) Clearance

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

K012663 · Sedecal USA, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2001
Decision
18d
Days
Class 2
Risk

K012663 is an FDA 510(k) clearance for the EASY MOVING MOBILE X-RAY UNIT (MODEL SM-HF). Classified as System, X-ray, Mobile (product code IZL), Class II - Special Controls.

Submitted by Sedecal USA, Inc. (Deer Field, US). The FDA issued a Cleared decision on August 31, 2001 after a review of 18 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 Sedecal USA, Inc. devices

Submission Details

510(k) Number K012663 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2001
Decision Date August 31, 2001
Days to Decision 18 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 107d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 95
Devices cleared under the same product code (IZL) and FDA review panel - the closest regulatory comparables to K012663.
GE TETHERED PORTABLE DIGITAL RADIOGRAPHIC DETECTOR
K041922 · General Electric Co. · Jul 2004
3D NAVIGATION INTERFACE FOR SIREMOBILE ISO-C 3D
K022337 · Siemens Medical Solutions USA, Inc. · Aug 2002
AMX-4 PLUS MOBILE X-RAY SYSTEM
K021016 · GE Medical Systems · Jun 2002
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
MX MOBILE X-RAY SYSTEM
K862452 · Philips Medical Systems (Cleveland), Inc. · Jul 1986