510(k) K810716

X-RAY IMAGE INTENSIFIER PRODUCTS by Instrumentation Camera, Inc. — Product Code JAA

K810716 is an FDA 510(k) premarket notification submitted by Instrumentation Camera, Inc. for the device "X-RAY IMAGE INTENSIFIER PRODUCTS". The FDA issued a decision of Substantially Equivalent on April 23, 1981. The device falls under product code JAA (System, X-Ray, Fluoroscopic, Image-Intensified), a Class II device regulated under 21 CFR 892.1650. Instrumentation Camera, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 1981
Date Received
March 17, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Fluoroscopic, Image-Intensified
Device Class
Class II
Regulation Number
892.1650
Review Panel
RA
Submission Type