510(k) K940696

SYNCRA TILT OPTION FOR ANGIO DIAGNOST 5 by Philips Medical Systems North America, Inc. — Product Code KXJ

K940696 is an FDA 510(k) premarket notification submitted by Philips Medical Systems North America, Inc. for the device "SYNCRA TILT OPTION FOR ANGIO DIAGNOST 5". The FDA issued a decision of Substantially Equivalent on March 16, 1994. The device falls under product code KXJ (Table, Radiologic), a Class II device regulated under 21 CFR 892.1980. Philips Medical Systems North America, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 16, 1994
Date Received
February 16, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table, Radiologic
Device Class
Class II
Regulation Number
892.1980
Review Panel
RA
Submission Type