CINA-ASPECTS
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Basic Information
- Brand Name
- CINA-ASPECTS
- Primary DI
- B826CINAASPECTS150
- Version / Model
- 1.5
- Company Name
- AVICENNA.AI
- Labeler DUNS
- 271198112
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-03-29
- Public Version
- 1
- Public Version Date
- 2024-04-08
- Public Version Status
- New
- Public Device Record Key
- 9697623c-ce54-4a68-89b3-57b422338a6e
Device Description
CINA-ASPECTS is a computer-aided diagnosis (CADx) software device used to assist the clinician in the assessment and characterization of brain tissue abnormalities using CT image data. The Software automatically reorients images, segments and analyzes ASPECTS Regions of lnterest (ROIs). CINA-ASPECTS extracts image data for the ROI(s) to provide analysis and computer analytics based on morphological characteristics. The imaging features are then synthesized by an artificial intelligence algorithm into a single ASPECT (Alberta Stroke Program Early CT) Score. CINA-ASPECTS is indicated for evaluation of patients presenting for diagnostic imaging workup with known MCA or ICA occlusion, for evaluation of extent of disease. Extent of disease refers to the number of ASPECTS regions affected which is reflected in the total score. This device provides information that may be useful in the characterization of early ischemic (acute) brain tissue injury during image interpretation. CINA-ASPECTS provides a comparative analysis to the ASPECTS standard of care radiologist assessment using the ASPECTS region definitions and highlighting ROIs and numerical scoring
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
- 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
- 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 |
|---|---|---|---|---|
| POK | Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer | Radiology | 892.2060 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57812 | Radiology DICOM image processing application software | A software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/disc burning) and/or image quality manipulation and quantification (e.g., non-interpretive graphical overlays). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B826CINAASPECTS150 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K233342 | 000 |