ROOGRAPH EVO, MODEL 9307XY11Z1, ROTOGRAPH EVO D, MODEL 9307XY1191

Unit, X-ray, Extraoral With Timer

VILLA SISTEMI MEDICALI S.P.A.

The following data is part of a premarket notification filed by Villa Sistemi Medicali S.p.a. with the FDA for Roograph Evo, Model 9307xy11z1, Rotograph Evo D, Model 9307xy1191.

Pre-market Notification Details

• Device ID: K090749
• 510k Number: K090749
• Device Name: ROOGRAPH EVO, MODEL 9307XY11Z1, ROTOGRAPH EVO D, MODEL 9307XY1191
• Classification: Unit, X-ray, Extraoral With Timer
• Applicant: VILLA SISTEMI MEDICALI S.P.A. VIA DELLE AZALEE 3 Buccinasco, IT 20090
• Contact: Paolo C Santin
• Correspondent: Paolo C Santin; VILLA SISTEMI MEDICALI S.P.A. VIA DELLE AZALEE 3 Buccinasco, IT 20090
• Product Code: EHD
• CFR Regulation Number: 872.1800 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-03-20
• Decision Date: 2009-05-18
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
08052870661418	K090749	000
08052870661210	K090749	000