510(k) · Cleared
ClearedCritical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems, LLC · QBS Radiological Computer Assisted Detection/Diagnosis Software For Fracture
Cleared on May 25, 2023 as substantially equivalent to K212365 (Gleamer, 2022) after a 185-day review. Its family tree reaches back 3 generations to 2018.
- Decided
- May 25, 2023
- Review
- 185 days
- Class
- Class II
- Product code
- QBS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN180005 (2018). No later device cites it as a predicate yet.
- Root · 3 generations backDEN180005 OsteoDetectImagen Technologies, Inc. · 2018
- 2 generations backK193417 FractureDetect (FX)Imagen Technologies, Inc. · 2020
- 1 generation backK212365 BoneViewGleamer · 2022
- This deviceK223491 Critical Care Suite with Pneumothorax Detection AI Algorithm…Ge Medical Systems, LLC · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN180005 | OsteoDetect | Imagen Technologies, Inc. | 2018 | — |
| −2 | K193417 | FractureDetect (FX) | Imagen Technologies, Inc. | 2020 | — |
| −1 | K212365 | BoneView | Gleamer | 2022 | — |
| 0 (this device) | K223491 | Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care… | Ge Medical Systems, LLC | 2023 | — |
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 QBS? 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 QBS device
- #1 K260378 Rayvolvescore 15.2 · 4 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 |
|---|---|---|---|
| * | K212365 | BoneViewSummary page 4…Names and Regulation: 21 CFR 892.2090 Product Code: Classification: Class II Product Codes: QBS Predicate BoneView (K212365) Device: Regulation Name: Radiological computer assisted detection and diagnosis software Reg… | 2022 |
| † | K183182 | Critical Care Suite | 2019 |
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 5 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K212365.
How does its category compare?
All QBS devicesQBS Radiological Computer Assisted Detection/Diagnosis Software For Fracture: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QBS
3so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · QBS
123in 2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QBS
No recall names QBS since 2007.
Adverse event reports per year · QBS
No MAUDE report names QBS since 2007.
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 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 3 | 123 | 0 | — |
What is it indicated for?
Critical Care Suite with Pneumothorax Detection Al Algorithm is a computer-aided triage, notification, and diagnostic device that analyzes frontal chest X-ray images for the presence of a pneumothorax. Critical Care Suite identifies and highlights images with a pneumothorax to enable case prioritization or triage and assist as a concurrent reading aide during interpretation of radiographs. Intended users include qualified independently licensed…
Read the full statement (134 words)
Critical Care Suite with Pneumothorax Detection Al Algorithm is a computer-aided triage, notification, and diagnostic device that analyzes frontal chest X-ray images for the presence of a pneumothorax. Critical Care Suite identifies and highlights images with a pneumothorax to enable case prioritization or triage and assist as a concurrent reading aide during interpretation of radiographs.
Intended users include qualified independently licensed healthcare professionals (HCPs) trained to independently assess the presence of pneumothoraxes in radiographic images and radiologists.
Critical Care Suite should not be used in-lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis. It is not intended to replace the review of the X-ray image by a qualified physician. Critical Care Suite is indicated for adults and Transitional Adolescents (18 to <22 years old but treated like adults).
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/K223491 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223491: Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223491
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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