Cleared Traditional

K801368 - A2 IMAGE PROCESSING SYSTEM (FDA 510(k) Clearance)

K801368 · Medtronic Vascular · Radiology device

Jul 1980

Decision

41d

Days

Class 1

Risk

K801368 is an FDA 510(k) clearance for the A2 IMAGE PROCESSING SYSTEM. This device is classified as a Camera, Scintillation (gamma) (Class I - General Controls, product code IYX).

Submitted by Medtronic Vascular (Walker, US). The FDA issued a Cleared decision on July 21, 1980, 41 days after receiving the submission on June 10, 1980.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1100.

Submission Details

510(k) Number	K801368 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 10, 1980
Decision Date	July 21, 1980
Days to Decision	41 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	—

Device Classification

Product Code	IYX — Camera, Scintillation (gamma)
Device Class	Class I - General Controls
CFR Regulation	21 CFR 892.1100