FDA UDI
In Commercial Distribution
🇺🇸 United States
FireCR
DI: 08809466040016
·
Model: FR01
·
Digiray Corp.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- FireCR
- Primary DI
- 08809466040016
- Version / Model
- FR01
- Catalog Number
- CG-701
- Company Name
- Digiray Corp.
- Labeler DUNS
- 557815751
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-06-20
- Public Version
- 5
- Public Version Date
- 2020-02-07
- Public Version Status
- Update
- Public Device Record Key
- 5d9fbcc7-3df3-4b02-8e7e-0f7032d614bd
Device Description
The FireCR System is ideal for Computed Radiography examinations in busy clinics and specialty practices. Affordable, rugged, compact, lightweight, fast and effective FireCR System enables all imaging functions to be performed with the advanced image management software, a solution that can be adapted most clinical applications.
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
- Yes
- 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 |
|---|---|---|---|---|
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | Radiology | 892.1680 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35928 | Radiography digital imaging scanner | A laser or light-based optical unit designed to convert medical images originally captured on x-ray film or phosphor storage plate (PSP) into a digital format. Examples of this device include devices employing video frame grabbers, and scanners which use lasers or charge-coupled devices. Depending on the design, the digitized images can then be digitally transferred from location to location, archived, or used with other digital image processing, analysis or recording systems. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08809466040016 | GS1 |
Customer Contacts
- Phone
- +82429312100
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 30 | Kilogram | |
| Width | 46.4 | Centimeter | |
| Length | 70.3 | Centimeter | |
| Height | 11.7 | Centimeter |