Software For Endoscopy Procedure Metrics
- US Product Code (FDA)
- SBXView Product Code Classification →
- US Risk Class (FDA)
- Class 2
- US Regulation (CFR)
- 21 CFR 876.1500View CFR Regulation →
- Medical specialty
- Gastroenterology, Urology
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Not Eligible
Software that analyzes gastrointestinal (i.e., esophagus, stomach, small bowel, and colon) endoscopy procedure¿data to assess or document the procedure metrics such as completeness of the endoscopic procedure conducted by an appropriately trained healthcare provider; and to provide feedback to the healthcare provider on procedural metrics that are part of the standard of care. The health care provider is responsible for verifying and interpreting the procedural metric data with regard to patient management. The software function does not aid the healthcare provider in the detection of lesions nor does the software function aid the healthcare provider to identify characteristics of the patient, anatomy, or lesion that may be used for diagnosis of a disease or condition.¿The software does not output treatment recommendations.
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Software For Endoscopy Procedure Metrics is a medical device type in the Gastroenterology, Urology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.
View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.