Cleared Traditional

DIGIRAD SYSTEM 1 AND THE REUSUABLE IMAGE MEDIA

K852284 · Digirad Corp. · Radiology
Nov 1985
Decision
169d
Days
Class 2
Risk

About This 510(k) Submission

K852284 is an FDA 510(k) clearance for the DIGIRAD SYSTEM 1 AND THE REUSUABLE IMAGE MEDIA, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Digirad Corp. (Palo Alto, US). The FDA issued a Cleared decision on November 14, 1985, 169 days after receiving the submission on May 29, 1985. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K852284 FDA.gov
FDA Decision Cleared SESE
Date Received May 29, 1985
Decision Date November 14, 1985
Days to Decision 169 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary —

Device Classification

Product Code LLZ — System, Image Processing, Radiological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050