Adaptix Ortho350

Primary DI
05061068070003
Brand
Adaptix Ortho350
Company
ADAPTIX LIMITED
Model
AD01-0850
Device description
The Adaptix Ortho350 (K252133) is a 3D tomographic X-ray device intended to generate tomosynthesis images of human anatomy for diagnostic purposes of body extremities, upper/lower limbs, and adjacent anatomy in all routine radiography examinations. The device comprises of an Ortho350 C-Arm Assembly and a Control PC. It is also possible to create 2D X-ray images of the desired anatomy.The Adaptix Ortho350 device is a portable system that can be placed on a benchtop or the floor or mounted on an optional cart for added mobility. To obtain 3D tomosynthesis images, the relevant area of the patient is positioned against the detector cover then X-rays are emitted from a controlled sequence of locations. The system uses a low-power, monoblock X-ray source with integrated controls and feedback, synchronized electronically with the detector for tomosynthesis image acquisition. The system is operated by an X-ray technologist or suitably qualified healthcare professional using and designed with safety features to only allow X-ray emission when multiple controls are in place.
Published
2025-11-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IZFSystem, X-Ray, Tomographic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IZFSystem, X-Ray, TomographicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K252133000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252133000Adaptix Ortho350Adaptix Limited2025-11-06IZF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05061068070003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05061068070003050610680700035061068070003

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure57 KiloPascal106 KiloPascal
Storage Environment Humidity30 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius55 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+441865634406support.ortho@adaptix.com

Regulatory Flags#

DUNS number
211583185
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290018465066TAP2DNANO-X IMAGING LTDIZF2026-02-18
07290018465011Nanox.ARC XNANO-X IMAGING LTDIZF2025-09-04
04547410556438DR-ID 900MCFUJIFILM CORPORATIONIZF2025-04-04
04547410556452DR-ID 900MCFUJIFILM CORPORATIONIZF2025-04-04
07290018465004Nanox.ARCNANO-X IMAGING LTDIZF2023-10-26
00195278070265DefiniumGE Hualun Medical Systems Co., LtdIZF2020-11-24
00195278118356DefiniumGE Hualun Medical Systems Co., LtdIZF2020-11-24
00840682138598DiscoveryGE Hualun Medical Systems Co., LtdIZF2018-11-05
08054890480055CLISIS SYSTEMSGENERAL MEDICAL MERATE SPAIZF2018-07-11
08054890480109Discovery RF180GENERAL MEDICAL MERATE SPAIZF2018-07-11
04547410306651DR-ID 900MCFUJIFILM CORPORATIONIZF2016-09-16
04547410307061DR-ID 900MCFUJIFILM CORPORATIONIZF2016-09-16
00840682115322DiscoveryGE Hualun Medical Systems Co., LtdIZF2016-05-26