FDA.reportPublic FDA data

Nanox.ARC

Primary DI
07290018465004
Brand
Nanox.ARC
Company
NANO-X IMAGING LTD
Model
2.2.
Published
2023-10-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IZFSystem, X-Ray, TomographicRadiology2
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)Radiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222934000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222934000Nanox.ARCNano-X Imaging , Ltd.2023-04-28IZF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290018465004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290018465004072900184650047290018465004

GMDN Terms#

Term, Definition table
TermDefinition
Multi-directional tomography x-ray systemAn assembly of devices used to produce 2-dimensional cross-sectional (tomographic) images on x-ray film at a fixed angle and depth in relation to body position by coordinating a prescribed pattern of non-linear x-ray tube motion (elliptical, circular, clover shaped, spiral, as well as linear, depending on the system design) during exposure sequences. This approach causes the shadow of the selected plane to remain stationary on the moving film while the shadows in both directions of the plane have a relative displacement on the film and are either obliterated or blurred. This GMDN code reflects old technology, now superseded by computed tomography (CT) systems.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
521092973
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290018465066TAP2D1.02026-02-18
07290018465011Nanox.ARC XNanox.ARC X2025-09-04

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
08055186671089A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLMQB2026-04-02
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