Cleared Traditional

K882358 - PULSED FLUOROSCOPIC CONTROL MODEL:PF-02

K882358 is an FDA 510(k) clearance for PULSED FLUOROSCOPIC CONTROL MODEL:PF-02, manufactured by U.S. Imaging, Inc.. The device is a Class 2 Radiology device with product code IZI cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K882358 · U.S. Imaging, Inc. · Radiology device
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Oct 1988
Decision
134d
Days
Class 2
Risk

K882358 is an FDA 510(k) clearance for the PULSED FLUOROSCOPIC CONTROL MODEL:PF-02. Classified as System, X-ray, Angiographic (product code IZI), Class II - Special Controls.

Submitted by U.S. Imaging, Inc. (Greensburg, US). The FDA issued a Cleared decision on October 19, 1988 after a review of 134 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1600 - 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 U.S. Imaging, Inc. devices

FDA 510(k) Submission Details - K882358

510(k) Number K882358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 1988
Decision Date October 19, 1988
Days to Decision 134 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 107d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IZI Device Classification - Class 2, Special Controls

Product Code IZI System, X-ray, Angiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1600
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 - IZI System, X-ray, Angiographic

All 168
Devices cleared under the same product code (IZI) and FDA review panel - the closest regulatory comparables to K882358.
IMAGER
K883831 · Fischer Imaging Corp. · Nov 1988
ADVANTAGE
K883860 · Fischer Imaging Corp. · Nov 1988
SIEMENS PACS/I-A
K880690 · Siemens Gammasonics, Inc. · Oct 1988
DIGITRON 2, DIGITAL SUBSTRACTION ANGIO. SYSTEM
K883072 · Siemens Gammasonics, Inc. · Sep 1988
SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-200
K874910 · Shimadzu Precision Instruments, Inc. · Jul 1988
SHIMADZU CATHETERIZATION C-ARM STAND ER-200
K875372 · Shimadzu Precision Instruments, Inc. · Feb 1988