Cleared Traditional

K861279 - FLUORO PLUS (FDA 510(k) Clearance)

K861279 · Advantage Medical Systems, Inc. · Radiology device

Jun 1986

Decision

70d

Days

Class 2

Risk

K861279 is an FDA 510(k) clearance for the FLUORO PLUS. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Advantage Medical Systems, Inc. (Millburn, US). The FDA issued a Cleared decision on June 16, 1986, 70 days after receiving the submission on April 7, 1986.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K861279 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 07, 1986
Decision Date	June 16, 1986
Days to Decision	70 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	-