FALCON

Transducer, Ultrasonic

VIASONIX LTD.

The following data is part of a premarket notification filed by Viasonix Ltd. with the FDA for Falcon.

Pre-market Notification Details

• Device ID: K111416
• 510k Number: K111416
• Device Name: FALCON
• Classification: Transducer, Ultrasonic
• Applicant: VIASONIX LTD. 1 ODELL PLAZA Yonkers, NY 10701
• Contact: William Stern
• Correspondent: William Stern; VIASONIX LTD. 1 ODELL PLAZA Yonkers, NY 10701
• Product Code: JOP
• CFR Regulation Number: 870.2880 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-05-20
• Decision Date: 2011-07-15
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07290016880021	K111416	000
07290016880496	K111416	000
07290016880502	K111416	000
07290016880519	K111416	000
07290016880526	K111416	000
07290016880465	K111416	000
07290016880472	K111416	000
07290016880397	K111416	000
07290016880403	K111416	000
07290016880410	K111416	000
07290016880076	K111416	000
07290016880168	K111416	000
07290016880175	K111416	000
07290016880182	K111416	000
07290016880007	K111416	000
07290016880014	K111416	000
07290016880489	K111416	000