Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9616014

FEI Number

3002675731

Entity Name

ARCOMA AB

City/State/Country

VAXJO Kronoberg, SE

Establishment Address

ANNAVAGEN 1, VAXJO Kronoberg S-352 46, SE

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

ARCOMA AB (Owner Number: 9035990)

Owner / Operator Contact Address

ANNAVAGEN 1, --, VAXJO, SE-NOTA SE-325 46, SE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ARCOCOMB ARCO TABLE NT ARCOCEIL 0047-BT Urology table 0047-CV Vascular Imaging Table 0047-T Elite and Precision Imaging Table

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IXY	Holder, Radiographic Cassette, Wall-Mounted	Radiology	Class 1	892.1880	1999-01-26
IZZ	Table, Radiographic, Non-Tilting, Powered	Radiology	Class 2	892.1980	1999-08-10
IYB	Tube Mount, X-Ray, Diagnostic	Radiology	Class 1	892.1770	1998-12-24
IXR	Table, Radiographic, Tilting	Radiology	Class 2	892.1980	2007-02-26

Official Correspondent

Henrik Blomdahl

US Agent Details

Gary Becker Business: Tara Systems Inc Email: tarasystemsinc@gmail.com Phone: (561) 2126985

Related Public Records

Same Entity

ARCOMA AB

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
K951176	Siemens Medical Solutions USA, Inc.	KOORDINAT M	1995-04-20

Similar Registrations

Registration Number	Establishment Name	Location
9710585	KENEX (ELECTRO-MEDICAL) LTD.	HARLOW Essex, GB
2243057	Accogent Pausch	Tinton Falls, NJ, US
3003202425	SIEMENS SHANGHAI, MEDICAL EQUIPMENT LTD.	SHANGHAI, CN
3003768251	Philips Medical Systems DMC GmbH	HAMBURG, DE
3014403439	DK MEDICAL SYSTEMS CO., LTD.	Pyeongtaek-si Gyeonggi, KR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9616014. Last updated year: 2026. Please use registration number 9616014 when referencing this establishment in official correspondence.