SBXClass II

Software For Endoscopy Procedure Metrics

21 CFR 876.1500 / Gastroenterology, Urology

SBX is the FDA product code for Software For Endoscopy Procedure Metrics, a class II device type, regulated under 21 CFR 876.1500. FDA's definition for this code reads: "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...". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code: SBX
Device name: Software For Endoscopy Procedure Metrics
FDA 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.
Regulation: 21 CFR 876.1500
Device class: Class II
Review panel: Gastroenterology, Urology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 0

Companies listing this code with FDA

Companies whose registered establishments list this code

Odin Medical Limited

Recent clearances

Product code SBX

FDA records hold no clearances under product code SBX.

Recent recalls

Product code SBX

FDA records show no recalls under product code SBX.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)