Data / Medical devices / Sweden / Arcoma AB

Arcoma AB: FDA-registered device maker in VAXJO Kronoberg, Sweden, 1 510(k) clearance

Name: Arcoma AB FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Arcoma AB is registered with the FDA (registration 9616014) in VAXJO Kronoberg, Sweden. It lists 6 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 3, 2014. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 9616014
FEI number: 3002675731
Address: Annavagen 1, VAXJO Kronoberg, Sweden, S-352 46
Owner or operator: ARCOMA AB (9035990)
Roles: Complaint file establishment, Contract manufacturer, Manufacturer
First device listed: December 24, 1998
Registered through: 2026
Brand names listed: 0047-BT Urology table, 0047-CV Vascular Imaging Table, 0047-T Elite and Precision Imaging Table, ARCO TABLE NT, ARCOCEIL, ARCOCOMB, Omnera 400A, Omnera 400T and more

Devices it lists

Device	Product code	Class	Role	Source
Holder, Radiographic Cassette, Wall-Mounted	IXY	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Solid State X-Ray Imager (Flat Panel/Digital Imager)	MQB	2	Manufacturer	accessdata.fda.gov
System, X-Ray, Stationary	KPR	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Table, Radiographic, Non-Tilting, Powered	IZZ	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Table, Radiographic, Tilting	IXR	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Tube Mount, X-Ray, Diagnostic	IYB	1	Complaint file establishment, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
June 3, 2014	K140683	0180 INTUITION, 0072 PRECISION	KPR	Substantially Equivalent	Arcoma AB	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
May 5, 2021	90446	Class II	Ongoing	Omnera 400T Digital Radiographic System	There is the potential for the X-Ray system to short circuit due to an ingress of liquid in the display handles which may result in uncontrolled movement of the Overhead Tube Crane (OTC).	accessdata.fda.gov

Compare with other makers

Updated July 5, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.