OMNIDOS

Accelerator, Linear, Medical

SCANDITRONIX MEDICAL AB

The following data is part of a premarket notification filed by Scanditronix Medical Ab with the FDA for Omnidos.

Pre-market Notification Details

• Device ID: K011763
• 510k Number: K011763
• Device Name: OMNIDOS
• Classification: Accelerator, Linear, Medical
• Applicant: SCANDITRONIX MEDICAL AB STALGATAN 14 Uppsala S-754 50, SE S-754 50
• Contact: Alf Ohman
• Correspondent: Alf Ohman; SCANDITRONIX MEDICAL AB STALGATAN 14 Uppsala S-754 50, SE S-754 50
• Product Code: IYE
• CFR Regulation Number: 892.5050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-06-07
• Decision Date: 2001-09-05
• Summary: summary