OMNERA 500A

GUDID 07350008750098

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

Stationary basic diagnostic x-ray system, digital

• Primary Device ID: 07350008750098
• NIH Device Record Key: 2f0c33db-867d-415d-982f-03874cc50e4d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OMNERA 500A
• Version Model Number: Precision i5
• Company DUNS: 356774109
• Company Name: Arcoma AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +46470706900
• Email: service@arcoma.se
• Phone: +46470706900
• Email: service@arcoma.se
• Phone: +46470706900
• Email: service@arcoma.se
• Phone: +46470706900
• Email: service@arcoma.se
• Phone: +46470706900
• Email: service@arcoma.se
• Phone: +46470706900
• Email: service@arcoma.se
• Phone: +46470706900
• Email: service@arcoma.se
• Phone: +46470706900
• Email: service@arcoma.se
• Phone: +46470706900
• Email: service@arcoma.se
• Phone: +46470706900
• Email: service@arcoma.se
• Phone: +46470706900
• Email: service@arcoma.se
• Phone: +46470706900
• Email: service@arcoma.se
• Phone: +46470706900
• Email: service@arcoma.se
• Phone: +46470706900
• Email: service@arcoma.se
• Phone: +46470706900
• Email: service@arcoma.se

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350008750098 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140683

FDA Product Code

• MOB: Test System, Antineutrophil Cytoplasmic Antibodies (Anca)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-04-07
• Device Publish Date: 2022-03-30

Devices Manufactured by Arcoma AB

• 07350008750098 - OMNERA 500A: 2022-04-07Stationary x-ray system intended for obtaining radiographic images portions of the human body in a clinical environment. The device is not intended for mammography.
• 07350008750098 - OMNERA 500A: 2022-04-07 Stationary x-ray system intended for obtaining radiographic images portions of the human body in a clinical environment. The dev
• 07350008750012 - RadPRO OMNERA 400A: 2018-03-29 Stationary x-ray system intended for obtaining radiographic images portions of the human body in a clinical environment. The dev
• 07350008750050 - RadPRO OMNERA 400T: 2018-03-29 Stationary x-ray system intended for obtaining radiographic images of various portions of the human body in a clinical environme