Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030186509

FEI Number

3030186509

Entity Name

X3D APS

City/State/Country

Kvistgaard Hovedstaden, DK

Establishment Address

Oldenvej 33, Kvistgaard Hovedstaden 3490, DK

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

X3D ApS (Owner Number: 10089603)

Owner / Operator Contact Address

Oldenvej 33, Kvistgaard, DK-84 3490, DK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K011611

PMA Number

N/A

All Registered Proprietary Names

CapIMAGE SoloMobile CorCam CARDIO MD CardioMD

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IYX	Camera, Scintillation (Gamma)	Radiology	Class 1	892.1100	2023-12-29
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2023-12-22

Official Correspondent

Thomas Nielsen

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

X3D ApS

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

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

Registration Number	Establishment Name	Location
3023006704	SMARTBREAST CORPORATION, INC.	Sherman Oaks, CA, US
9710645	HERMES MEDICAL SOLUTIONS, AB	STOCKHOLM, SE
3017754782	RADIOPHARMACEUTICAL IMAGING & DOSIMETRY, LLC	Baltimore, MD, US
3014954414	CONVERGENT IMAGING SOLUTIONS	Ottawa Ontario, CA
3027338963	GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING	Haifa, IL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030186509. Last updated year: 2026. Please use registration number 3030186509 when referencing this establishment in official correspondence.