Adaptix Ortho350
Basic Information
- Brand Name
- Adaptix Ortho350
- Primary DI
- 05061068070003
- Version / Model
- AD01-0850
- Company Name
- ADAPTIX LIMITED
- Labeler DUNS
- 211583185
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-11-19
- Public Version
- 1
- Public Version Date
- 2025-11-27
- Public Version Status
- New
- Public Device Record Key
- ce30d68c-4a86-4bb9-9389-dc6fb81fb163
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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IZF | System, X-Ray, Tomographic | Radiology | 892.1740 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37660 | Multi-directional tomography x-ray system | An 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05061068070003 | GS1 |
Customer Contacts
- Phone
- +441865634406
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K252133 | 000 |
Storage Conditions
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 57 – 106 KiloPascal
- Type
- Storage Environment Humidity
- Temperature Range
- 30 – 70 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 55 Degrees Celsius