Cleared Traditional

K860193 - PORTALCAST
(FDA 510(k) Clearance)

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

K860193 is an FDA 510(k) clearance for the PORTALCAST, a Block, Beam-shaping, Radiation Therapy (Class II — Special Controls, product code IXI), submitted by Diacor, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on January 30, 1986, 8 days after receiving the submission on January 22, 1986. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5710.

Submission Details

510(k) Number K860193 FDA.gov
FDA Decision Cleared SESE
Date Received January 22, 1986
Decision Date January 30, 1986
Days to Decision 8 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary —

Device Classification

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