FDA UDI
In Commercial Distribution
🇺🇸 United States
HDR X-ray Source 2.2
DI: 00858012005304
·
Model: 720697
·
Icad, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- HDR X-ray Source 2.2
- Primary DI
- 00858012005304
- Version / Model
- 720697
- Catalog Number
- S7551
- Company Name
- Icad, Inc.
- Labeler DUNS
- 108870254
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-20
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- f15a4ff8-e687-4a11-85b6-896ca61a7609
Device Description
Axxent HDR X-Ray Source 50 cm HUT
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
- 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 |
|---|---|---|---|---|
| JAD | System, Therapeutic, X-Ray | Radiology | 892.5900 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59678 | Intraoperative/postoperative therapeutic x-ray system x-ray source | A mains electricity (AC-powered) electronic component of an intraoperative/postoperative therapeutic x-ray system designed to generate the x-ray radiation for use primarily in the treatment of cancer (e.g., breast, brain, skin), typically during or after an operation for tumour resection. It uses voltages typically less than 50 kV to accelerate electrons through a drift tube onto a gold target where low energy x-ray radiation is generated and emitted isotropically. It is typically used with (covered by) various applicators for the different clinical applications, and mounted on a mobile (on wheels) floor stand. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00858012005304 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K122951 | 000 |