FDA UDI
In Commercial Distribution
🇺🇸 United States
Nyquist.IQ
DI: 00853901007032
·
Model: IPS-100
·
OMEGA MEDICAL IMAGING, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Nyquist.IQ
- Primary DI
- 00853901007032
- Version / Model
- IPS-100
- Company Name
- OMEGA MEDICAL IMAGING, LLC
- Labeler DUNS
- 622534493
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-03-17
- Public Version
- 1
- Public Version Date
- 2022-03-25
- Public Version Status
- New
- Public Device Record Key
- 98c37fdf-40b3-4782-95ae-ed0fac72a5bb
Device Description
Digital Medical Image Processor
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
- Yes
- 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 |
|---|---|---|---|---|
| LLZ | System, Image Processing, Radiological | Radiology | 892.2050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40847 | X-ray system computer, diagnostic, general-purpose | A dedicated mainframe computer, personal computer (PC) or PC based platform and associated hardware, firmware, and operating system software used specifically to control and monitor the operation of a general-purpose medical x-ray system and associated image processing, display and analysis functions. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00853901007032 | GS1 |