FDA UDI
In Commercial Distribution
🇺🇸 United States
MRIdian A3i Software
DI: 00850036816027
·
Model: A3i
·
VIEWRAY INCORPORATED
Product Codes
2
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MRIdian A3i Software
- Primary DI
- 00850036816027
- Version / Model
- A3i
- Company Name
- VIEWRAY INCORPORATED
- Labeler DUNS
- 015705677
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-05-05
- Public Version
- 1
- Public Version Date
- 2022-05-13
- Public Version Status
- New
- Public Device Record Key
- 75751bdf-d1b0-4376-8c6a-1dba6db675c0
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
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| IYE | Accelerator, Linear, Medical | Radiology | 892.5050 | 2 |
| LNH | System, Nuclear Magnetic Resonance Imaging | Radiology | 892.1000 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35159 | Linear accelerator system | An assembly of devices designed to produce high-energy electrons to yield high-energy x-rays used for therapeutic applications, primarily to treat cancer. It provides a uniform radiation field of uniform intensity and predictable energy level, in a beam with well defined dimensions. The principle of operation is linear acceleration of electrons by means of electromagnetic (EM) microwaves. The output is used as a treatment beam on the patient, either directly or after passing a suitable target. The system typically includes signal analysis and display devices, patient and device supports, and software. | No | Active |
| 62147 | Stereotactic teletherapy radionuclide system, MRI-imaging | A stationary assembly of computer-based devices designed to simultaneously create magnetic resonance imaging (MRI) images and deliver gamma radiation from a radionuclide source (typically cobalt) for stereotactic-radiosurgical therapy, typically to treat malignant tumours; the MRI images can be used to monitor treatment in real-time. It consists of radiation-emitting heads and collimators in a rotating gantry assembly; a magnet MRI system for soft-tissue imaging; patient couch and integrated positioning system; control consoles for image acquisition, planning and treatment administration; and integrated software. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850036816027 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K212958 | 000 |