Sonosite PX Ultrasound System

System, Imaging, Pulsed Doppler, Ultrasonic

FUJIFILM SonoSite, Inc.

The following data is part of a premarket notification filed by Fujifilm Sonosite, Inc. with the FDA for Sonosite Px Ultrasound System.

Pre-market Notification Details

• Device ID: K200964
• 510k Number: K200964
• Device Name: Sonosite PX Ultrasound System
• Classification: System, Imaging, Pulsed Doppler, Ultrasonic
• Applicant: FUJIFILM SonoSite, Inc. 21919 30th Drive SE Bothell, WA 98021 -3904
• Contact: Sudipta Chakrabarti
• Correspondent: Prithul Bom; REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114
• Product Code: IYN
• Subsequent Product Code: ITX
• Subsequent Product Code: IYO
• CFR Regulation Number: 892.1550 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2020-04-10
• Decision Date: 2020-05-08

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00841517109912	K200964	000
00841517109882	K200964	000
00841517109950	K200964	000
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00841517109707	K200964	000
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00841517110000	K200964	000
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00841517105884	K200964	000