ATLANTIS

Unit, X-ray, Intraoral

TROPHY RADIOLOGIE

The following data is part of a premarket notification filed by Trophy Radiologie with the FDA for Atlantis.

Pre-market Notification Details

• Device ID: K953936
• 510k Number: K953936
• Device Name: ATLANTIS
• Classification: Unit, X-ray, Intraoral
• Applicant: TROPHY RADIOLOGIE 106, RUE DE LA JARRY B.P. 20 Vincennes, Cedex (paris), FR 94307
• Contact: Marie-pierre Labat-camy
• Correspondent: Marie-pierre Labat-camy; TROPHY RADIOLOGIE 106, RUE DE LA JARRY B.P. 20 Vincennes, Cedex (paris), FR 94307
• Product Code: EAP
• CFR Regulation Number: 872.1810 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-08-21
• Decision Date: 1995-12-28