Cleared Traditional

K921425 - SCD-105 AND SCD-125 CAPACITOR DISCHARGE MOBILE X-R

K921425 is an FDA 510(k) clearance for SCD-105 AND SCD-125 CAPACITOR DISCHARGE..., manufactured by Acoma Medical Imaging, Inc.. The device is a Class 2 Radiology device with product code IZL cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K921425 · Acoma Medical Imaging, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1992
Decision
156d
Days
Class 2
Risk

K921425 is an FDA 510(k) clearance for the SCD-105 AND SCD-125 CAPACITOR DISCHARGE MOBILE X-R. Classified as System, X-ray, Mobile (product code IZL), Class II - Special Controls.

Submitted by Acoma Medical Imaging, Inc. (Wheeling, US). The FDA issued a Cleared decision on August 27, 1992 after a review of 156 days - an extended review 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: 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 Acoma Medical Imaging, Inc. devices

FDA 510(k) Submission Details - K921425

510(k) Number K921425 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1992
Decision Date August 27, 1992
Days to Decision 156 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
49d slower than avg
Panel avg: 107d · This submission: 156d
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 155
Devices cleared under the same product code (IZL) and FDA review panel - the closest regulatory comparables to K921425.
MOBILETT PLUS MOBILE X-RAY SYSTEM
K932106 · Siemens Medical Solutions USA, Inc. · Sep 1994
REPLACEMENT BATERY FOR GE AMX-4 PORT. X-RAY MACH.
K931483 · Portable Power Systems, Inc. · Feb 1994
BATTERY PACK
K924798 · Portable Power Systems, Inc. · Oct 1992
VMX MOBILE X-RAY SYSTEM
K910902 · GE Medical Systems · Sep 1991
MINXRAY P300 X-RAY SYSTEM
K911841 · Minxray, Inc. · Aug 1991
MC125L-50 SHIMADZU MOBILE X-RAY SYSTEM
K893637 · Shimadzu Medical Systems · Jul 1989