Cleared Traditional

K920115 - MEDISCINT
(FDA 510(k) Clearance)

K920115 · Oakfield Instruments, Ltd. · Radiology

Mar 1992

Decision

77d

Days

Class 1

Risk

K920115 is an FDA 510(k) clearance for the MEDISCINT. This device is classified as a Probe, Uptake, Nuclear (Class I — General Controls, product code IZD).

Submitted by Oakfield Instruments, Ltd. (Oxon Ox8 1ja England, GB). The FDA issued a Cleared decision on March 30, 1992, 77 days after receiving the submission on January 13, 1992.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1320.

Submission Details

510(k) Number	K920115 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 13, 1992
Decision Date	March 30, 1992
Days to Decision	77 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF