Cleared Traditional

K884621 - DIGISCAN (FDA 510(k) Clearance)

K884621 · Siemens Medical Solutions USA, Inc. · Radiology device

Apr 1989

Decision

173d

Days

Class 2

Risk

K884621 is an FDA 510(k) clearance for the DIGISCAN. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Siemens Medical Solutions USA, Inc. (Iselin, US). The FDA issued a Cleared decision on April 26, 1989, 173 days after receiving the submission on November 4, 1988.

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

Submission Details

510(k) Number	K884621 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 04, 1988
Decision Date	April 26, 1989
Days to Decision	173 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	—