Cleared Traditional

XISCAN MODEL 1000 (K852346) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K852346 · Xi Tech · Radiology device
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Mar 1986
Decision
283d
Days
Class 2
Risk

K852346 is an FDA 510(k) clearance for the XISCAN MODEL 1000. Classified as System, X-ray, Fluoroscopic, Image-intensified (product code JAA), Class II - Special Controls.

Submitted by Xi Tech (Randolph, US). The FDA issued a Cleared decision on March 10, 1986 after a review of 283 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1650 - 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 Xi Tech devices

Submission Details

510(k) Number K852346 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1985
Decision Date March 10, 1986
Days to Decision 283 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
176d slower than avg
Panel avg: 107d · This submission: 283d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JAA System, X-ray, Fluoroscopic, Image-intensified
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
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 - JAA System, X-ray, Fluoroscopic, Image-intensified

All 72
Devices cleared under the same product code (JAA) and FDA review panel - the closest regulatory comparables to K852346.
UNIVERSAL ABC CONTROLER
K883580 · Philips Medical Systems (Cleveland), Inc. · Jan 1989
LP LATERAL FLUORO POSITIONER (B5077A)
K872061 · General Electric Co. · Jun 1987
SCX SYSTEM
K862120 · General Electric Co. · Jun 1986
PET-SCOPE II IMAGE INTENSIFIER
K855213 · Philips Medical Systems (Cleveland), Inc. · Jan 1986
DIGITAL FLUOROGRAPHIC X-RAY SYSTEM
K833530 · General Electric Co. · Nov 1983
LATERAL ANGULATING FLUORO SUSPENSION
K820184 · General Electric Co. · Feb 1982