510(k) K894935

S-70 PORTABLE DENTAL X-RAY SYSTEM by Lorad Medical Systems, Inc. — Product Code EHD

K894935 is an FDA 510(k) premarket notification submitted by Lorad Medical Systems, Inc. for the device "S-70 PORTABLE DENTAL X-RAY SYSTEM". The FDA issued a decision of Substantially Equivalent on April 25, 1990. The device falls under product code EHD (Unit, X-Ray, Extraoral With Timer), a Class II device regulated under 21 CFR 872.1800. Lorad Medical Systems, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 1990
Date Received
August 3, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, X-Ray, Extraoral With Timer
Device Class
Class II
Regulation Number
872.1800
Review Panel
RA
Submission Type