Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030982377

FEI Number

3030982377

Entity Name

IONIC HEALTH TECHNOLOGIES SA

City/State/Country

Sao Jose dos Campos Sao Paulo, BR

Establishment Address

Estrada Dr. Altino Bondensan, 500, Sala 1103 Eugenio de Melo, Sao Jose dos Campos Sao Paulo 12247-016, BR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

IONIC HEALTH TECHNOLOGIES SA (Owner Number: 10090684)

Owner / Operator Contact Address

Estrada Dr. Altino Bondensan, 500, Sala 1103 Eugenio de Melo, São José dos Campos, BR-SP 12247-016, BR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K233660

PMA Number

N/A

All Registered Proprietary Names

Ionic Health

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2024-04-29
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2024-04-29
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2024-04-29
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2024-04-29

Official Correspondent

Jose Coelho

US Agent Details

JOSE COELHO Email: jlcoelho@ionic.health Phone: (917) 2440254

Related Public Records

Same Entity

IONIC HEALTH TECHNOLOGIES SA

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K033956	Is2 Research, Inc.	MOBILE SINGLE CIRCULAR CAMERA (MSC) & MOBILE DIGITAL CARDIAC CAMERA (MDCC)	2004-01-20
K923309	GE Medical Systems	ARGUS PET SYSTEM	1992-09-29
K101768	Miegmbh	MIE SCINTRON GAMMA CAMERA SYSTEMS	2010-10-05
K080013	Agfa Healthcare Corporation	REGISTRATION AND FUSION	2008-01-17
K042221	Barco NV Barcoview	CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM	2004-12-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0005-2016	Toshiba American Medical Systems Inc	2	Celesteion PCA-9000A/2 PET/CT System
Z-0012-05	General Electric Med Systems LLC	2	Emission Computed Tomography System. Including Model numbers: 2200967, ASM001080, ASM001083, ASM001092, ASM001099, ASM000085, 10036800109, and Varicam.
Z-0013-2007	Philips Medical Systems (Cleveland) Inc	2	Nuclear medicine systems: Gemini 16, Model 4535 679 28961. Gemini GXL, Models # 4535 679 71891, #4535 679 75681, #4535 679 75691. Precedence, Model #2169 -3000A, #2169-3001A, #2169-3002A, and 2169-3003A. PET/CT Computed tomography systems.
Z-0014-2007	Philips Medical Systems (Cleveland) Inc	2	Brilliance(a) CT 6 slice, Model #4535 670 73191. Brilliance(a) CT 10 Slice, Model 4535 670 73181. Brilliance 16 Slice, Model #4535 670 78851. Brilliance CT 16 Power, Model #4535 670 23331. Brilliance CT 40 Slice, Model #4550 110 04011. Brilliance CT Big Bore, Model #4535 670 88051. Computed tomography systems.
Z-0024-2014	GE Healthcare, LLC	2	GE PET Discovery 610, PET Discovery 710. Intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging.

Similar Registrations

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9614698	CANON INC.	OTAWARA-SHI Tochigi, JP
3011950073	United Imaging Healthcare North America, Inc	Houston, TX, US
3008962177	GENERAL EQUIPMENT FOR MEDICAL IMAGING, S.A.	Valencia, ES

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030982377. Last updated year: 2026. Please use registration number 3030982377 when referencing this establishment in official correspondence.