510(k) K981227

SYMPHONY 360 REMOTE CONTROL TABLE by Acoma Medical Imaging, Inc. — Product Code JAA

K981227 is an FDA 510(k) premarket notification submitted by Acoma Medical Imaging, Inc. for the device "SYMPHONY 360 REMOTE CONTROL TABLE". The FDA issued a decision of Substantially Equivalent on June 30, 1998. The device falls under product code JAA (System, X-Ray, Fluoroscopic, Image-Intensified), a Class II device regulated under 21 CFR 892.1650. Acoma Medical Imaging, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 1998
Date Received
April 3, 1998
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