Cleared Traditional

K945043 - BATTERY PACK #PMX120-18A

K945043 is the FDA 510(k) clearance for BATTERY PACK #PMX120-18A by Portable Power Systems, Inc.. It is a Class 2 Radiology device (product code IZL) cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K945043 · Portable Power Systems, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1995
Decision
98d
Days
Class 2
Risk

K945043 is an FDA 510(k) clearance for the BATTERY PACK #PMX120-18A. Classified as System, X-ray, Mobile (product code IZL), Class II - Special Controls.

Submitted by Portable Power Systems, Inc. (Castle Rock, US). The FDA issued a Cleared decision on January 20, 1995 after a review of 98 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 Portable Power Systems, Inc. devices

Submission Details

510(k) Number K945043 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1994
Decision Date January 20, 1995
Days to Decision 98 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
9d faster than avg
Panel avg: 107d · This submission: 98d
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 118
Devices cleared under the same product code (IZL) and FDA review panel - the closest regulatory comparables to K945043.
AMX-4 PLUS MOBILE X-RAY SYSTEM
K021016 · GE Medical Systems · Jun 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