Cleared Traditional

K902460 - CARDIOSCINT (LEFT VENTRICULAR FUNCTION MONITOR)
(FDA 510(k) Clearance)

K902460 · Oakfield Instruments, Ltd. · Radiology

Aug 1990

Decision

85d

Days

Class 1

Risk

K902460 is an FDA 510(k) clearance for the CARDIOSCINT (LEFT VENTRICULAR FUNCTION MONITOR). 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 August 28, 1990, 85 days after receiving the submission on June 4, 1990.

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

Submission Details

510(k) Number	K902460 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 04, 1990
Decision Date	August 28, 1990
Days to Decision	85 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	—