# DEN210032: AccuMeasure System

- Pathway: De Novo (Direct)
- Applicant: RQMIS, Inc.
- Decided: Jul 26, 2022 after 351 days
- Product code: QTH (Endoscopic Light-Projecting Measuring Device)
- Device class: 2
- Regulation: 21 CFR 876.1530
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K223827: FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01 (2023), 1 descendant of its own
- K261880: FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01 (2026), 0 descendants of its own

## Indications for use
The AccuMeasure System is intended to be used as an accessory in conjunction with an endoscope to measure observable anatomy and pathology in the gastrointestinal tract. The AccuMeasure System provides no therapeutic or diagnostic function.

Source page: https://510kreport.com/device/DEN210032
Methodology: https://510kreport.com/methodology