DIGORA

System, Imaging, X-ray, Electrostatic

ORION CORPORATION SOREDEX

The following data is part of a premarket notification filed by Orion Corporation Soredex with the FDA for Digora.

Pre-market Notification Details

• Device ID: K934949
• 510k Number: K934949
• Device Name: DIGORA
• Classification: System, Imaging, X-ray, Electrostatic
• Applicant: ORION CORPORATION SOREDEX NILSIANKATU 10-14 Helsinki, FI Fin-00510
• Contact: Kai Laner
• Correspondent: Kai Laner; ORION CORPORATION SOREDEX NILSIANKATU 10-14 Helsinki, FI Fin-00510
• Product Code: IXK
• CFR Regulation Number: 892.1630 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1993-10-18
• Decision Date: 1994-02-10