Cleared Traditional

DIGIRAD REUSABLE IMAGE MEDIA

K854407 · Digirad Corp. · Radiology
Mar 1986
Decision
129d
Days
Class 1
Risk

About This 510(k) Submission

K854407 is an FDA 510(k) clearance for the DIGIRAD REUSABLE IMAGE MEDIA, a Media, Reusable Image (Class I — General Controls, product code LQA), submitted by Digirad Corp. (Palo Alto, US). The FDA issued a Cleared decision on March 10, 1986, 129 days after receiving the submission on November 1, 1985. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1840.

Submission Details

510(k) Number K854407 FDA.gov
FDA Decision Cleared SESE
Date Received November 01, 1985
Decision Date March 10, 1986
Days to Decision 129 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary —

Device Classification

Product Code LQA — Media, Reusable Image
Device Class Class I — General Controls
CFR Regulation 21 CFR 892.1840