Cleared Traditional

K860193 - PORTALCAST

K860193 is an FDA 510(k) clearance for PORTALCAST, manufactured by Diacor, Inc.. The device is a Class 2 Radiology device with product code IXI cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K860193 · Diacor, Inc. · Radiology device
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Jan 1986
Decision
8d
Days
Class 2
Risk

K860193 is an FDA 510(k) clearance for the PORTALCAST. Classified as Block, Beam-shaping, Radiation Therapy (product code IXI), Class II - Special Controls.

Submitted by Diacor, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on January 30, 1986 after a review of 8 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5710 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K860193

510(k) Number K860193 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1986
Decision Date January 30, 1986
Days to Decision 8 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 107d · This submission: 8d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IXI Device Classification - Class 2, Special Controls

Product Code IXI Block, Beam-shaping, Radiation Therapy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5710
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 - IXI Block, Beam-shaping, Radiation Therapy

All 50
Devices cleared under the same product code (IXI) and FDA review panel - the closest regulatory comparables to K860193.
VARIAN MULTILEAF COLLIMATOR
K893464 · Varian Assoc., Inc. · Aug 1989
DCD-1 (DIGITAL CONTOUR DETECT-RADIAT THERAPY) SYST
K883317 · S & S X-Ray Products, Inc. · Apr 1989
HUESTIS COMPU-FORMER
K880047 · Huestis Machine Corp. · Apr 1988
DG 200/300 DIGITAL ANGIOGRAPHIC SYSTEM
K852353 · Thomson-Cgr Medical Corp. · Aug 1985
CLARK PRECISION BLOCK CUTTER, COOLING
K842615 · Clark Research and Development, Inc. · Sep 1984
MYVACET 5-07, 7-00 AND 9-40
K791178 · Radiation Products Design, Inc. · Sep 1979
K860193 · PORTALCAST
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