FDA UDI
In Commercial Distribution
🇺🇸 United States
ImagingRing m
DI: 19120075320112
·
Model: 2
·
medPhoton GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ImagingRing m
- Primary DI
- 19120075320112
- Version / Model
- 2
- Catalog Number
- P04-1
- Company Name
- medPhoton GmbH
- Labeler DUNS
- 300376801
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-05-28
- Public Version
- 1
- Public Version Date
- 2025-06-05
- Public Version Status
- New
- Public Device Record Key
- da142e57-2502-4b19-b4ce-17b7ab21b731
Device Description
ImagingRing m, Version 2: Mobile (within an imaging facility) assembly of diagnostic x-ray computed tomography (CT) and fluoroscopic devices intended to acquire, display and process both: 1) two- and/or three-dimensional (3-D) cross-sectional (tomographic) images; and 2) real-time fluoroscopic images, from any part of the body for a variety of applications.
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
- Labeling does not contain MRI Safety Information
- 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 |
|---|---|---|---|---|
| OWB | Interventional Fluoroscopic X-Ray System | Radiology | 892.1650 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65365 | Multi-modality diagnostic x-ray system, mobile | A mobile assembly of diagnostic x-ray devices intended to acquire, display and process images from any part of the body (full-body) incorporating the techniques of more than one x-ray imaging modality, typically including real-time fluoroscopy, two-dimensional (2D) radiography, and computed tomography (CT); it is not a single-modality system. It typically consists of a gantry with x-ray tubes and opposing detectors that rotate rapidly, console, monitor and patient bed. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 19120075320112 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K234067 | 000 |