510(k) · Cleared
ClearedqXR-BT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Qure.Ai Technologies · QIH Automated Radiological Image Processing Software
Cleared on Dec 21, 2021 as substantially equivalent to K123526 (Riverain Technologies, 2012) after a 118-day review. Its family tree reaches back 7 generations to 1986.
- Decided
- Dec 21, 2021
- Review
- 118 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K862120 (1986). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK862120 SCX SystemGeneral Electric Co. · 1986 · Recalled
- 6 generations backK982196 Digital Radiographic Imaging SystemGE Medical Systems · 1998
- 5 generations backK992066 Revolution TX/I Digital Radiographic Table SystemGE Medical Systems · 1999
- 4 generations backK012389 Revolution XR/D Digital Radiographic Imaging SystemGe Medical Systems, Inc. · 2001 · Recalled
- 3 generations backK013481 Dual Energy and Tissue Equalization Software OptionGE Medical Systems · 2001
- 2 generations backK092363 Softview, Model 2.01Riverain Medical Group · 2010
- 1 generation backK123526 Clearread +ConfirmRiverain Technologies · 2012
- This deviceK212690 qXR-BTQure.Ai Technologies · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K862120 | SCX System | General Electric Co. | 1986 | 3 |
| −6 | K982196 | Digital Radiographic Imaging System | GE Medical Systems | 1998 | — |
| −5 | K992066 | Revolution TX/I Digital Radiographic Table System | GE Medical Systems | 1999 | — |
| −4 | K012389 | Revolution XR/D Digital Radiographic Imaging System | Ge Medical Systems, Inc. | 2001 | 4 |
| −3 | K013481 | Dual Energy and Tissue Equalization Software Option | GE Medical Systems | 2001 | — |
| −2 | K092363 | Softview, Model 2.01 | Riverain Medical Group | 2010 | — |
| −1 | K123526 | Clearread +Confirm | Riverain Technologies | 2012 | — |
| 0 (this device) | K212690 | qXR-BT | Qure.Ai Technologies | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 2004 | 1 | 0 |
| 2012 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QIH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QIH device
- #1 K213998 cvi42 Auto Imaging Software Applicationscore 23.5 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K123526 | Clearread +ConfirmSummary page 4…EVICE Name of Device: ClearRead+Confirm Image Processing System Manufacturer: Riverain Technologies LLC 510(k) Number: K123526 4 INTENDED USE / INDICATIONS FOR USE: The qXR-BT device is intended to generate a secondary digital chest X-ray image tha… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 35 years and passes through 6 companies; a new generation was cleared every 2.8 years on median.
- 5 of the 10 ancestors have a recall of any class.
- 1 other device also cites its predicate K123526.
How does its category compare?
All QIH devicesQIH Automated Radiological Image Processing Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · QIH
94in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QIH
150in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QIH
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QIH
4in 2025
MAUDE reports naming product code QIH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 11 | 145 | 0 | 0 |
| 2021 | 19 | 125 | 0 | 0 |
| 2022 | 25 | 134 | 0 | 0 |
| 2023 | 45 | 151 | 0 | 0 |
| 2024 | 64 | 141 | 0 | 2 |
| 2025 | 94 | 150 | 0 | 4 |
| 2026 | 78 | 130 | 1 | — |
What is it indicated for?
The qXR-BT device is intended to generate a secondary digital chest X-ray image that facilitates confirmation of the position of a breathing tube and an anatomical landmark on adult chest X-rays. This device is intended for use by licensed physicians who are trained in the evaluation of breathing tube placement on chest X-rays. The qXR-BT image provides adjunctive information and is not a substitute for the original PA/AP image.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K212690 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212690: qXR-BT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212690
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026