# K123526: Clearread +Confirm

- Pathway: 510(k) (Traditional)
- Applicant: Riverain Technologies
- Decided: Dec 27, 2012 after 42 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K862120 (1986). 9 ancestors in all.
25 later devices descend from it; 2 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092363: Softview, Model 2.01, Riverain Medical Group (2010) Summary page 1.
- K120062: DRX-Revolution Mobile X-Ray System, Carestream Health, Inc. (2012). Our reading of the summary gave K129062, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “DRX-Revolution”.

## Most influential descendants
- K162278: Digital Diagnostic Mobile X-ray System (2016), 23 descendants of its own
- K171119: GM85 (2017), 22 descendants of its own
- K173828: GU60A & GU60A-65 (2018), 19 descendants of its own
- K180543: GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85 (2018), 18 descendants of its own
- K181626: Digital Diagnostic Mobile X-ray System (2018), 10 descendants of its own

## Indications for use
ClearRead +Confirm is intended to generate an enhanced, secondary digital radiographic image of the chest to facilitate confirmation of line/tubes. The enhanced AP or PA image of the chest provides improved visibility of lines and tubes. The ClearRead +Confirm image provides adjunctive information and is not a substitute for the original PA/AP image. This device is intended to be used by trained professionals, such as physicians, radiologists, and technicians, on patients with lines and tubes and is not intended to be used on pediatric patients.

Source page: https://510kreport.com/device/K123526
Methodology: https://510kreport.com/methodology