ARCOMA AB

Matched from indexed company URL: Arcoma AB

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
9616014	3002675731	ARCOMA AB	1	N	2026-01-01	ANNAVAGEN 1 VAXJO Kronoberg SE S-352 46

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
07350008750012	OMNERA 400A - Stationary x-ray system intended for obtaining radiographic images portions of the human body in a clinical environment. The device is not intended for mammography.	+46(0)470706970	service@arcoma.se
07350008750050	OMNERA 400T - Stationary x-ray system intended for obtaining radiographic images of various portions of the human body in a clinical environment. The device is not intended for mammography.	+46(0)740706970	service@arcoma.se
07350008750098	OMNERA 500A - Stationary x-ray system intended for obtaining radiographic images portions of the human body in a clinical environment. The device is not intended for mammography.	+46470706900	service@arcoma.se

arcoma.se

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
18167	1340311738	K140683	0180 INTUITION, 0072 PRECISION	KPR	2014-06-03
18167	1497992040	K113855	PANORAD, PANORAD SL	KPR	2012-01-25
18167	1620153655	K101435	IMIX PANORAD AND SOMARAD	KPR	2010-09-15
18167	1601592810	K093427	FDR ACSELERATE SYSTEM, DR-ID 200 FLAT PANEL DETECTOR	MQB	2010-01-21
18167	1317185122	K073632	INTUITION, MODEL 0170	KPR	2008-01-10
18167	1824562835	K073114	IMIX INSIGHT X-RAY SYSTEMS	KPR	2008-01-17
18167	1338207926	K072867	IMIX 2000 DIGITAL RADIOGRAPHY SYSTEM, MODELS UNV 3K, UNV 3KW, UNV 4K	KPR	2007-11-21
18167	1709154561
18167	1730589214
18167	1767428561
18167	1888041100
18167	2060227273

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
KPR	6	2014-06-03
MQB	1	2010-01-21

PMN#

0180 INTUITION, 0072 PRECISION

2014-06-03

ARCOMA AB

INTUITION, MODEL 0170

2008-01-10

ARCOMA AB

GUDID#

OMNERA 500A - Stationary x-ray system intended for obtaining radiographic images portions of the human body in a clinical environment. The device is not intended for mammography.

Arcoma AB

2022-03-30

OMNERA 400A - Stationary x-ray system intended for obtaining radiographic images portions of the human body in a clinical environment. The device is not intended for mammography.

Arcoma AB

2017-12-04

OMNERA 400T - Stationary x-ray system intended for obtaining radiographic images of various portions of the human body in a clinical environment. The device is not intended for mammography.

Arcoma AB

2017-12-04