Cleared Traditional

K945043 - BATTERY PACK #PMX120-18A

K945043 is an FDA 510(k) clearance for BATTERY PACK #PMX120-18A, manufactured by Portable Power Systems, Inc.. The device is a Class 2 Radiology device with 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

FDA 510(k) Submission Details - K945043

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
Combination Product No
PCCP Authorized No
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.

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 176
Devices cleared under the same product code (IZL) and FDA review panel - the closest regulatory comparables to K945043.
ACU-RAY HF SERIES PORTABLE X-RAY UNIT
K972204 · Sterne Equipment Co., Ltd. · Oct 1997
SEALED LEAD ACID BATTERY PACK
K970234 · Portable Power Systems, Inc. · May 1997
MOBILE X-RAY SYSTEM
K955036 · Shimadzu Corp. · Dec 1995
MINXRAY HF80H HIGH FREQUENCY DIAGNOSTIC X-RAY UNIT
K945707 · Minxray, Inc. · Jan 1995
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