Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1423348

FEI Number

3000210013

Entity Name

MIE AMERICA, INC.

City/State/Country

ELK GROVE VILLAGE, IL, US

Establishment Address

420 BENNETT RD., ELK GROVE VILLAGE, IL 60007, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

MIE GMBH (Owner Number: 9028781)

Owner / Operator Contact Address

Hauptstrasse 112, --, Seth, DE-NOTA 23845, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K101768

PMA Number

N/A

All Registered Proprietary Names

SCINTRON ANCORIS MIE - LFOV SCINTRON MIE - ORBITER SCINTRON MIE - SD-X 37 SCINTRON MIE - DIACAM SCINTRON ECAM SCINTRON

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	2012-12-28
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2020-11-03
IYX	Camera, Scintillation (Gamma)	Radiology	Class 1	892.1100	2007-12-05
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2007-12-05
KPS	System, Tomography, Computed, Emission	Radiology	Class 2	892.1200	2012-12-28

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MIE GMBH

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3005128583	MIE GMBH	SETH Schleswig-Holstein, DE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K101768	Miegmbh	MIE SCINTRON GAMMA CAMERA SYSTEMS	2010-10-05
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

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.

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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 1423348. Last updated year: 2026. Please use registration number 1423348 when referencing this establishment in official correspondence.