FDA.reportPublic FDA data

A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRL

Primary DI
08055186671225
Brand
A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRL
Company
A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRL
Model
ARCO FP-Rk0521S
Catalog number
74 09 000-1
Device description
This is a mobile X-ray device with a Flat Panel detector used for radiological guidance and visualization during diagnostic, interventional and surgical procedures. In particular, the device is to be applied during orthopedic, neuro, abdominal, vascular, thoracic and cardiac procedures. It can be used on all patients except pediatric patients within the limit of the device.
Published
2026-05-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
OWBInterventional Fluoroscopic X-Ray System
OXOImage-Intensified Fluoroscopic X-Ray System, Mobile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OWBInterventional Fluoroscopic X-Ray SystemRadiology2
OXOImage-Intensified Fluoroscopic X-Ray System, MobileRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182086000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182086000ARCO FPA.T.S. Applicazione Tecnologie Speciali S.R.L.2019-08-20OWB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08055186671225PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08055186671225080551866712258055186671225

GMDN Terms#

Term, Definition table
TermDefinition
Mobile general-purpose fluoroscopic x-ray system, digitalA mobile (within an imaging facility) general-purpose diagnostic fluoroscopic x-ray system that uses a C-arm and digital techniques for image capture, display and manipulation and is designed to be used in a variety of general-purpose applications requiring real-time fluoroscopic imaging capabilities. It includes spot-film capabilities in addition to the fluoroscopic features and is intended to optimize the capability of users to visually and quantitatively evaluate the anatomy and physiological function of various targeted body areas in real-time. It is frequently used in conjunction with an ingested or injected x-ray contrast medium. Images can be both real-time and delayed formats.

Regulatory Flags#

DUNS number
440069847
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08055186671232A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLARCO FP-Rk2021S74 09 000-22026-05-21
08055186671249A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLARCO FP-Rk0530S74 10 000-12026-05-21
08055186671256A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLARCO FP-Rk2030S74 10 000-22026-05-21
08055186671089A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLPRIMO S2026-04-02
08055186671096FUJIFILM Healthcare Americas CorporationPersona C HR74 13 0002025-07-02
08055186670112FUJIFILM Medical Systems U.S.A. Inc.Persona C74 09 000-1 / 74 11 000-12021-09-20
08055186670396AMRAD MedicalAgility Plus74 09 000-12022-03-25
08055186670402AMRAD MedicalAgility Plus74 09 000-22022-03-25
08055186670419AMRAD MedicalAgility Plus74 10 000-12022-03-25
08055186670426AMRAD MedicalAgility Plus74 10 000-22022-03-25
08055186670433AMRAD MedicalAgility95 01 0002022-03-25
08055186670440AMRAD MedicalAgility95 02 0002022-03-25
08055186670334FUJIFILM Healthcare Americas CorporationPersona C74 09 000-12021-10-24
08055186670341FUJIFILM Healthcare Americas CorporationPersona C74 09 000-22021-10-24
08055186670358FUJIFILM Healthcare Americas CorporationPersona C74 10 000-12021-10-24
08055186670365FUJIFILM Healthcare Americas CorporationPersona C74 10 000-22021-10-24
08055186670372FUJIFILM Healthcare Americas CorporationPersona CS95 01 0002021-10-24
08055186670389FUJIFILM Healthcare Americas CorporationPersona CS95 02 0002021-10-24
08055186670129FUJIFILM Medical Systems U.S.A. Inc.Persona C74 09 000-22021-09-20
08055186670136FUJIFILM Medical Systems U.S.A. Inc.Persona C74 10 000-12021-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08055186671232A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOXO2026-05-21
08055186671232A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOWB2026-05-21
08055186671249A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOXO2026-05-21
08055186671249A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOWB2026-05-21
08055186671256A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOXO2026-05-21
08055186671256A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOWB2026-05-21
00198715128956AngiowaveAngioWave Imaging, LLCOWB2026-05-09
B225100000220Orthoscan TAU MVP 1515Ziehm-Orthoscan, Inc.OXO2026-04-30
B225100000230Orthoscan TAU MVP 2020Ziehm-Orthoscan, Inc.OXO2026-04-30
08809365283033SG HealthcareSG Healthcare Co., Ltd.OWB2026-04-24
08809244060533GenorayGENORAY CO., LTD.OWB2026-04-10
08809244060557GenorayGENORAY CO., LTD.OWB2026-04-10
08809244060632GenorayGENORAY CO., LTD.OWB2026-04-10
00198953052488AlliaGE MEDICAL SYSTEMSOWB2025-12-17
00198953052488AlliaGE MEDICAL SYSTEMSOXO2025-12-17
08809244060601GenorayGENORAY CO., LTD.OWB2025-12-01
08809244060700GenorayGENORAY CO., LTD.OXO2025-12-01
B225100000200Orthoscan Versa Mini C-ArmZiehm-Orthoscan, Inc.OXO2025-07-11
08055186671096FUJIFILM Healthcare Americas CorporationA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLOXO2025-07-02
08800018422601EXTRON 3DRTECH CorporationOWB2025-06-17
08809244060090GenorayGENORAY CO., LTD.OXO2025-05-02
08809244060465GenorayGENORAY CO., LTD.OWB2025-05-02
07613327664089Philips HealthcareSTRYKER SUSTAINABILITY SOLUTIONS, INC.OWB2025-02-11
00195278685001OECGE Hualun Medical Systems Co., LtdOWB2025-01-09
00195278685001OECGE Hualun Medical Systems Co., LtdOXO2025-01-09
08053307591070TRIDENTTECHNIX SPAOWB2024-11-06
08053307591070TRIDENTTECHNIX SPAOXO2024-11-06
08053307591087TRIDENTTECHNIX SPAOWB2024-11-06
08053307591087TRIDENTTECHNIX SPAOXO2024-11-06
00643169618121O-armMEDTRONIC NAVIGATION, INC.OXO2024-10-10