PHANTOM

System, X-ray, Mobile

DYNARAD CORP.

The following data is part of a premarket notification filed by Dynarad Corp. with the FDA for Phantom.

Pre-market Notification Details

• Device ID: K941363
• 510k Number: K941363
• Device Name: PHANTOM
• Classification: System, X-ray, Mobile
• Applicant: DYNARAD CORP. 19 JEFRYN BLVD. WEST Deer Park, NY 11729
• Contact: Raymond Manez
• Correspondent: Raymond Manez; DYNARAD CORP. 19 JEFRYN BLVD. WEST Deer Park, NY 11729
• Product Code: IZL
• CFR Regulation Number: 892.1720 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-03-21
• Decision Date: 1994-07-20