Cleared Traditional

K860025 - MODEL MS-325 RADIOGRAPHIC X-RAY GENERATOR

K860025 is an FDA 510(k) clearance for MODEL MS-325 RADIOGRAPHIC X-RAY GENERATOR, manufactured by Medicor USA , Ltd.. The device is a Class 2 Radiology device with product code KPR cleared through the Traditional 510(k) pathway after a 124-day FDA review.

K860025 · Medicor USA , Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1986
Decision
124d
Days
Class 2
Risk

K860025 is an FDA 510(k) clearance for the MODEL MS-325 RADIOGRAPHIC X-RAY GENERATOR. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Medicor USA , Ltd. (Columbus, US). The FDA issued a Cleared decision on May 7, 1986 after a review of 124 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - 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 Medicor USA , Ltd. devices

FDA 510(k) Submission Details - K860025

510(k) Number K860025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 1986
Decision Date May 07, 1986
Days to Decision 124 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 107d · This submission: 124d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPR Device Classification - Class 2, Special Controls

Product Code KPR System, X-ray, Stationary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
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 - KPR System, X-ray, Stationary

All 288
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K860025.
BC 1400 HAND POSITIONER
K872316 · Instrumentation Industries, Inc. · Aug 1987
BC 1800 FINGER POSITIONER
K872317 · Instrumentation Industries, Inc. · Aug 1987
SCX INFORMATION MANAGEMENT SYSTEM
K870400 · General Electric Co. · Jun 1987
DIAMENTOR PATIENT X-RAY EXPOSURE INDICATOR 07302
K853753 · Victoreen, Inc. · Oct 1985
VRT TABLE W/INTEGRATING TUBE STAND/ELEV
K813173 · General Electric Co. · Dec 1981
DSS 500
K811934 · Philips Medical Systems (Cleveland), Inc. · Aug 1981