FDA product code SBX: Software For Endoscopy Procedure Metrics
SBX is the FDA product code for software for endoscopy procedure metrics. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel. Devices under SBX reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
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.
Classification
| Field | Value |
|---|---|
| Device name | Software For Endoscopy Procedure Metrics |
| Device class | Class II |
| Regulation | 21 CFR 876.1500 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
Recalls for SBX devices
openFDA lists no recalls for product code SBX.
Frequently asked questions
What is FDA product code SBX?
SBX is the FDA product code for software for endoscopy procedure metrics. It is a Class II device, regulated under 21 CFR 876.1500 and reviewed by the Gastroenterology and Urology panel.
What device class is SBX?
Class II, regulation 21 CFR 876.1500. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code SBX
- Run a recall and safety report across every SBX manufacturer
- Watch product code SBX for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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