Data / Medical devices / United States / Ultravision Corporation

Ultravision Corporation: FDA-registered device maker in North Palm Beach, FL, United States, 2 510(k) clearances

Name: Ultravision Corporation FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Ultravision Corporation is registered with the FDA (registration 3008223664) in North Palm Beach, FL, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated November 7, 2017. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3008223664
Address: 11662 Lake Shore Pl, North Palm Beach, FL, United States, 33408
Owner or operator: UltraVision Corporation (10050284)
Roles: Manufacturer
First device listed: October 29, 2015
Registered through: 2026
Brand names listed: UltraVision UVXR, UltraVision UVXS

Devices it lists

Device	Product code	Class	Role	Source
System, Imaging, Pulsed Doppler, Ultrasonic	IYN	2	Manufacturer	accessdata.fda.gov
System, Imaging, Pulsed Echo, Ultrasonic	IYO	2	Manufacturer	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
November 7, 2017	K173265	UltraVision 2 Diagnostic Ultrasound System	IYN	Substantially Equivalent	Winprobe Corporation	accessdata.fda.gov
April 7, 2015	K150580	UltraVision 2 Diagnostic Ultrasound System	IYO	Substantially Equivalent	Winprobe Corporation	accessdata.fda.gov

Compare with other makers

Updated November 7, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.