Data / Medical devices / Brazil / Ionic Health Technologies SA

Ionic Health Technologies SA: FDA-registered device maker in Sao Jose dos Campos Sao Paulo, Brazil, 1 510(k) clearance

Name: Ionic Health Technologies SA FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Ionic Health Technologies SA is registered with the FDA (registration 3030982377) in Sao Jose dos Campos Sao Paulo, Brazil. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 18, 2024. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Ionic Health Technologies SA

FDA registration number: 3030982377
Address: Estrada Dr. Altino Bondensan, 500, Sala 1103 Eugenio de Melo, Sao Jose dos Campos Sao Paulo, Brazil, 12247-016
Owner or operator: IONIC HEALTH TECHNOLOGIES SA (10090684)
Roles: Manufacturer
First device listed: April 29, 2024
Registered through: 2026
Brand names listed: Ionic Health

Devices it lists

Device	Product code	Class	Role	Source
System, Image Processing, Radiological	LLZ	2	Manufacturer	accessdata.fda.gov
System, Nuclear Magnetic Resonance Imaging	LNH	2	Manufacturer	accessdata.fda.gov
System, Tomography, Computed, Emission	KPS	2	Manufacturer	accessdata.fda.gov
System, X-Ray, Tomography, Computed	JAK	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
March 18, 2024	K233660	nCommand Lite System	LLZ	Substantially Equivalent	Ionic Health	accessdata.fda.gov

Compare with other makers

Updated March 18, 2024. 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.