FDA UDI
In Commercial Distribution
🇺🇸 United States
Omni
DI: 00195278901439
·
Model: Legend
·
GE Medical Systems, L.L.C.
Product Codes
2
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Omni
- Primary DI
- 00195278901439
- Version / Model
- Legend
- Company Name
- GE Medical Systems, L.L.C.
- Labeler DUNS
- 144879404
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-09-13
- Public Version
- 2
- Public Version Date
- 2026-02-09
- Public Version Status
- Update
- Public Device Record Key
- e889cc59-6b94-4073-9cd2-3702d3144178
Device Description
OMNI GANTRY 24-30 INCL. ELECTRONICS ASSY - WSO
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
- Yes
- 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 |
|---|---|---|---|---|
| JAK | System, x-ray, tomography, computed | Radiology | 892.1750 | 2 |
| KPS | System, tomography, computed, emission | Radiology | 892.1200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37618 | Full-body CT system | An assembly of diagnostic x-ray computed tomography (CT) devices with a gantry large enough to allow imaging of any part of the body. It includes designs with single or multiple fixed annular arrays of x-ray tubes and opposing detectors or those with x-ray tube(s) and opposing detector assemblies that rotate rapidly around a central axis point within the gantry imaging area. It can produce two and/or three-dimensional (3-D) cross-sectional (tomographic) images, including spiral CT or other special imaging applications at multiple specified angles in relation to body position. It may use a variety of digital techniques for information capture, image reconstruction, and display. | No | Active |
| 40644 | PET system | An assembly of devices comprising a diagnostic, positron emission tomography (PET) imaging system used to detect, record, quantify and analyse 511 kilo-electronvolt (keV) photon emission patterns resulting from annihilation reactions produced during the decay of positron emitting radiopharmaceuticals. It produces three-dimensional (3-D) tomographic digital cross-sectional physiological images representing distribution patterns of positron emitting radiopharmaceuticals ingested by, or injected into the patient. It typically uses lead collimators and specialized software for image reconstruction allowing mapping of metabolic patterns and rates associated with targeted physiological processes. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00195278901439 | GS1 |