EOSedge

System, X-ray, Stationary

EOS Imaging

The following data is part of a premarket notification filed by Eos Imaging with the FDA for Eosedge.

Pre-market Notification Details

• Device ID: K192079
• 510k Number: K192079
• Device Name: EOSedge
• Classification: System, X-ray, Stationary
• Applicant: EOS Imaging 10 Rue Mercoeur Paris, FR 75011
• Contact: Bernard Ismael
• Correspondent: Bernard Ismael; EOS Imaging 10 Rue Mercoeur Paris, FR 75011
• Product Code: KPR
• CFR Regulation Number: 892.1680 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-08-02
• Decision Date: 2019-11-27
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
03663999000108	K192079	000