Cleared Traditional

K950041 - SII 360 APR
(FDA 510(k) Clearance)

K950041 · Scott Imaging Intl., Inc. · Radiology

Mar 1995

Decision

75d

Days

Class 1

Risk

K950041 is an FDA 510(k) clearance for the SII 360 APR. This device is classified as a Generator, High-voltage, X-ray, Diagnostic (Class I — General Controls, product code IZO).

Submitted by Scott Imaging Intl., Inc. (Mobile, US). The FDA issued a Cleared decision on March 21, 1995, 75 days after receiving the submission on January 5, 1995.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1700.

Submission Details

510(k) Number	K950041 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 05, 1995
Decision Date	March 21, 1995
Days to Decision	75 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Statement