FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

VISION R/F TILTING TABLE

K Number: K000412 · Decision Apr 24, 2000
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
76
Applicant Total
13
Review Days
76

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Basic Information

Device Name
VISION R/F TILTING TABLE
K Number
K000412
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
892.1980
Medical Specialty
Radiology
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
Villa Sistemi Medicali S.P.A.
Date Received
February 8, 2000
Decision Date
April 24, 2000
Product Code
IXR
Advisory Committee
Radiology
Review Advisory Committee
RA
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
IXR Table, Radiographic, Tilting

Similar 510(k) Clearances

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Other Clearances by Villa Sistemi Medicali S.P.A.

K Number Device Name
K180601 Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology)
K162190 Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology)
K130109 ENDOGRAPH DC
K111152 ROTOGRAPH EVO 3D
K090749 ROOGRAPH EVO, MODEL 9307XY11Z1, ROTOGRAPH EVO D, MODEL 9307XY1191
K080859 DRF 4343
K050190 APOLLO
K030634 ENDOS DC
K030185 ENDOS AC/ACP
K002432 STRATO X
Search all 13 clearances from Villa Sistemi Medicali S.P.A. →