FDA UDI
In Commercial Distribution
🇺🇸 United States
O640 Upgrade
DI: 00840682123730
·
Model: H3100ZC
·
G E MEDICAL SYSTEMS ISRAEL LTD.
Product Codes
2
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- O640 Upgrade
- Primary DI
- 00840682123730
- Version / Model
- H3100ZC
- Company Name
- G E MEDICAL SYSTEMS ISRAEL LTD.
- Labeler DUNS
- 532102365
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-06-28
- Public Version
- 4
- Public Version Date
- 2019-08-16
- Public Version Status
- Update
- Public Device Record Key
- cdac6950-0298-4a0b-8ffe-ce8d10894938
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 |
| 40640 | Stationary gamma camera system | An assembly of static diagnostic devices designed to record, quantify, and analyse radionuclide emissions (primarily gamma rays) produced during the decay of radiopharmaceuticals or other radiation emitting materials injected into, or ingested by, a patient. It consists of an analogue or digital detector based nuclear medicine (NM) planar imaging system, crystal(s), a collimator and a set of photomultiplier tubes or photo diodes. Gamma rays pass through holes in the collimator causing light flashes within the crystal corresponding to the sites of origin in the body and the amplitude of the flash is calculated by a computer to create images. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840682123730 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K121019 | 000 |