FDA UDI
In Commercial Distribution
🇺🇸 United States
Rapid
DI: B761R60
·
Model: 6.x
·
Ischemaview, Inc.
Product Codes
5
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Rapid
- Primary DI
- B761R60
- Version / Model
- 6.x
- Company Name
- Ischemaview, Inc.
- Labeler DUNS
- 079477740
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-05-07
- Public Version
- 1
- Public Version Date
- 2025-05-15
- Public Version Status
- New
- Public Device Record Key
- 34196a84-2c45-43bc-8dac-613175a30a81
Device Description
Rapid Platform plus cleared indications for Rapid version 6.x
Device Characteristics
- Single Use
- Yes
- 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
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| QIH | Automated Radiological Image Processing Software | Radiology | 892.2050 | 2 |
| POK | Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer | Radiology | 892.2060 | 2 |
| LLZ | System, Image Processing, Radiological | Radiology | 892.2050 | 2 |
| QAS | Radiological Computer-Assisted Triage And Notification Software | Radiology | 892.2080 | 2 |
| QFM | Radiological Computer-Assisted Prioritization Software For Lesions | Radiology | 892.2080 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41670 | Radiological PACS software | An individual software application intended to be installed on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of radiological images. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B761R60 | HIBCC |
Customer Contacts
- Phone
- 303-704-2511
- [email protected]