Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device software for endoscopy procedure metrics
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.
Product CodeSBX
Regulation Number 876.1500
Device Class 2

-
-