Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1000246715

FEI Number

1000246715

Entity Name

ALKEN, INC. D/B/A POLHEMUS

City/State/Country

Colchester, VT, US

Establishment Address

40 Hercules Drive, Colchester, VT 05446, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Alken, Inc. d/b/a Polhemus (Owner Number: 10028587)

Owner / Operator Contact Address

40 Hercules Drive, Colchester, VT 05446, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K081787

PMA Number

N/A

All Registered Proprietary Names

FastSCAN II

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2026-04-28
MVA	Orthosis, Cranial	Neurology	Class 2	882.5970	2015-02-16
OAN	Orthosis, Cranial, Laser Scan	Neurology	Class 2	882.5970	2015-02-16

Official Correspondent

Skip Rodgers

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Alken, Inc. d/b/a Polhemus

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
K243523	Siemens Medical Solutions USA, Inc.	NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime	2025-02-12
K781431	General Electric Co.	ELECTRIC CT/T OPERATOR DISPLAY CONSOLE	1978-09-07
K231574	FUJIFILM Healthcare Americas Corporation	Scenaria View 4.2	2023-10-12
K233583	FUJIFILM Healthcare Americas Corporation	FCT iSTREAM Phase 1	2024-04-26
K151376	Covidien, LLC	superDimension Navigation System	2015-11-05

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2011	GE Medical Systems, LLC	2	HiSpeed X/i Computed Tomography operator consoles with the Model Number 2153675 and 2247802. The expected usage of this product is to generate head and whole body CT images of human subjects.
Z-0009-2017	Philips Medical Systems	2	Brilliance 64 CT Model Number 728231 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0010-2017	Philips Medical Systems	2	Ingenuity Core Model Number 728321 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0011-2017	Philips Medical Systems	2	Ingenuity Core 128 Model Number 728323 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0012-2017	Philips Medical Systems	2	Ingenuity CT Model Number 728326 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

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2134213	CANON MEDICAL INFORMATICS, INC.	MINNETONKA, MN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1000246715. Last updated year: 2026. Please use registration number 1000246715 when referencing this establishment in official correspondence.