510(k) K971452

MULTIX TOP/PRO RADIOGRAPHIC X-RAY TABLE by Siemens Medical Solutions USA, Inc. — Product Code IZZ

K971452 is an FDA 510(k) premarket notification submitted by Siemens Medical Solutions USA, Inc. for the device "MULTIX TOP/PRO RADIOGRAPHIC X-RAY TABLE". The FDA issued a decision of Substantially Equivalent on May 14, 1997. The device falls under product code IZZ (Table, Radiographic, Non-Tilting, Powered), a Class II device regulated under 21 CFR 892.1980. Siemens Medical Solutions USA, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 1997
Date Received
April 21, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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