Cleared Traditional

RESUBMITTED SCANORA

K884650 · Orion Corp. · Radiology
Mar 1989
Decision
129d
Days
Class 2
Risk

About This 510(k) Submission

K884650 is an FDA 510(k) clearance for the RESUBMITTED SCANORA, a System, X-ray, Tomographic (Class II — Special Controls, product code IZF), submitted by Orion Corp. (20101 Turku, FI). The FDA issued a Cleared decision on March 16, 1989, 129 days after receiving the submission on November 7, 1988. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1740.

Submission Details

510(k) Number K884650 FDA.gov
FDA Decision Cleared SESE
Date Received November 07, 1988
Decision Date March 16, 1989
Days to Decision 129 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary —

Device Classification

Product Code IZF — System, X-ray, Tomographic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1740