Cleared Traditional

THE ROBOLITE

K964460 · Shai Syg Motion and Innovations, Ltd. · Radiology

Jan 1997

Decision

78d

Days

Class 1

Risk

About This 510(k) Submission

K964460 is an FDA 510(k) clearance for the THE ROBOLITE, a Calculator/data Processing Module, For Clinical Use (Class I — General Controls, product code JQP), submitted by Shai Syg Motion and Innovations, Ltd. (Efrat, IL). The FDA issued a Cleared decision on January 24, 1997, 78 days after receiving the submission on November 7, 1996. This device falls under the Radiology review panel. Regulated under 21 CFR 862.2100.

Submission Details

510(k) Number	K964460 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 07, 1996
Decision Date	January 24, 1997
Days to Decision	78 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF