Cleared Traditional

SOLSTICE XRAY RING MARKER PAD

K925892 · Solstice Corp. · Radiology

May 1993

Decision

182d

Days

Class 1

Risk

About This 510(k) Submission

K925892 is an FDA 510(k) clearance for the SOLSTICE XRAY RING MARKER PAD, a System, X-ray, Film Marking, Radiographic (Class I — General Controls, product code JAC), submitted by Solstice Corp. (Portland, US). The FDA issued a Cleared decision on May 18, 1993, 182 days after receiving the submission on November 17, 1992. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1640.

Submission Details

510(k) Number	K925892 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 17, 1992
Decision Date	May 18, 1993
Days to Decision	182 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Statement