4Sight

System, Imaging, Pulsed Echo, Ultrasonic

ACCUTOME, INC.

The following data is part of a premarket notification filed by Accutome, Inc. with the FDA for 4sight.

Pre-market Notification Details

• Device ID: K152573
• 510k Number: K152573
• Device Name: 4Sight
• Classification: System, Imaging, Pulsed Echo, Ultrasonic
• Applicant: ACCUTOME, INC. 3222 PHOENIXVILLE PIKE Malvern, PA 19355
• Contact: Adam Pickholtz
• Correspondent: Adam Pickholtz; ACCUTOME, INC. 3222 PHOENIXVILLE PIKE Malvern, PA 19355
• Product Code: IYO
• CFR Regulation Number: 892.1560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-09-09
• Decision Date: 2015-11-25
• Summary: summary