FDA UDI
In Commercial Distribution
🇺🇸 United States
IMAGE DIAGNOSTICS, INC.
DI: 00850061871282
·
Model: ILEX DUO PLATINUM 32
·
IMAGE DIAGNOSTICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- IMAGE DIAGNOSTICS, INC.
- Primary DI
- 00850061871282
- Version / Model
- ILEX DUO PLATINUM 32
- Catalog Number
- A280-1569
- Company Name
- IMAGE DIAGNOSTICS, INC.
- Labeler DUNS
- 608235214
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-07-14
- Public Version
- 1
- Public Version Date
- 2025-07-22
- Public Version Status
- New
- Public Device Record Key
- 441bd3cc-583e-481e-83c6-754620251e57
Device Description
IDI,MOBILE VIDEO DISPLAY SYSTEM,DUAL 32IN. 4K MONITORS WITH RECORDER,ILEX DUO,120V,#A280-1569
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| LMD | System, Digital Image Communications, Radiological | Radiology | 892.2020 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40935 | Diagnostic x-ray digital imaging system workstation | A freestanding component of an x-ray-based diagnostic digital imaging assembly [e.g., a digital x-ray system, x-ray computed tomography (CT) system, or fluoroscopy system] designed to process patient radiological images; it may additionally be intended to be integrated as part of a radiology picture archiving and communication system (PACS). It consists of dedicated hardware (e.g., computer processing unit, monitor) with integrated software typically to assist image analysis (e.g., viewing, manipulation, interpretation); it does not include controls for direct operation of the imaging system. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850061871282 | GS1 |
Customer Contacts
- Phone
- 978-829-0009
- [email protected]