510(k) K000412

VISION R/F TILTING TABLE by Villa Sistemi Medicali S.P.A. — Product Code IXR

K000412 is an FDA 510(k) premarket notification submitted by Villa Sistemi Medicali S.P.A. for the device "VISION R/F TILTING TABLE". The FDA issued a decision of Substantially Equivalent on April 24, 2000. The device falls under product code IXR (Table, Radiographic, Tilting), a Class II device regulated under 21 CFR 892.1980. Villa Sistemi Medicali S.P.A. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 2000
Date Received
February 8, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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