FDA.reportPublic FDA data

A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRL

Primary DI
08055186671089
Brand
A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRL
Company
A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRL
Model
PRIMO S
Published
2026-04-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)Radiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211542000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211542000PRIMO SA.T.S. Applicazione Tecnologie Speciali S.R.L.2021-07-09MQB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08055186671089PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08055186671089080551866710898055186671089

GMDN Terms#

Term, Definition table
TermDefinition
Basic diagnostic x-ray system application software"An individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a general-purpose x-ray imaging system configuration. A basic set of applications programs and routines are included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some applications software routines or groups of routine packages must be combined with specific hardware or firmware accessories or configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and ""version"" or ""upgrade"" number."

Regulatory Flags#

DUNS number
440069847
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08055186671225A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLARCO FP-Rk0521S74 09 000-12026-05-21
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
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
08800011150129DRGEMDRGEM CorporationMQB2026-05-20
08800011150136DRGEMDRGEM CorporationMQB2026-05-20
08809413811096ExamVue ApexJPI HEALTHCARE. CO., LTD.MQB2026-05-14
08809413811126ExamVue ApexJPI HEALTHCARE. CO., LTD.MQB2026-05-14
08809413811133ExamVue ApexJPI HEALTHCARE. CO., LTD.MQB2026-05-14
B225100000220Orthoscan TAU MVP 1515Ziehm-Orthoscan, Inc.MQB2026-04-30
B225100000230Orthoscan TAU MVP 2020Ziehm-Orthoscan, Inc.MQB2026-04-30
08809365280001SG HealthcareSG Healthcare Co., Ltd.MQB2026-04-24
08809365281015SG HealthcareSG Healthcare Co., Ltd.MQB2026-04-24
00198953056103DefiniumGE Hualun Medical Systems Co., LtdMQB2026-02-12
00198953056158DefiniumGE Hualun Medical Systems Co., LtdMQB2026-02-12
00810035220546Radmedix AcuityDRe 1717tRADMEDIX, LLCMQB2025-10-28
00195278913814DefiniumGE Hualun Medical Systems Co., LtdMQB2025-09-05
08800011150112DRGEMDRGEM CorporationMQB2025-08-26
B225100000200Orthoscan Versa Mini C-ArmZiehm-Orthoscan, Inc.MQB2025-07-11
D0031000082900SchickDentsply International Inc.MQB2024-11-06
D0031000085860SchickDentsply International Inc.MQB2024-11-06
D0031000085870SchickDentsply International Inc.MQB2024-11-06
D0031000085880SchickDentsply International Inc.MQB2024-11-06
D0031000086260SchickDentsply International Inc.MQB2024-11-06
D0031000086300SchickDentsply International Inc.MQB2024-11-06
D0031000086350SchickDentsply International Inc.MQB2024-11-06
D0031000086360SchickDentsply International Inc.MQB2024-11-06
D0031000086380SchickDentsply International Inc.MQB2024-11-06
D0031000086390SchickDentsply International Inc.MQB2024-11-06
D0031000086410SchickDentsply International Inc.MQB2024-11-06
D0031000086520SchickDentsply International Inc.MQB2024-11-06
D0031000086530SchickDentsply International Inc.MQB2024-11-06
D0031000086540SchickDentsply International Inc.MQB2024-11-06
D0031000086550SchickDentsply International Inc.MQB2024-11-06