510(k) · Cleared
ClearedCritical Care Suite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems, LLC · QFM Radiological Computer-Assisted Prioritization Software For Lesions
Cleared on Aug 12, 2019 as substantially equivalent to K190362 (Zebra Medical Vision, Ltd., 2019) after a 266-day review. Its family tree reaches back 3 generations to 2018. 8 later devices descend from it.
- Decided
- Aug 12, 2019
- Review
- 266 days
- Class
- Class II
- Product code
- QFM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN170073 (2018). 8 later devices descend from it, 1 citing it directly.
- Root · 3 generations backDEN170073 ContaCTViz.Al, Inc. · 2018
- 2 generations backK183285 cmTriageCuremetrix, Inc. · 2019
- 1 generation backK190362 HealthPNXZebra Medical Vision, Ltd. · 2019
- This deviceK183182 Critical Care SuiteGe Medical Systems, LLC · 2019
- Descendant · cites it directly · 7 of its ownK211733 Lunit INSIGHT CXR TriageLunit, Inc. · 2021
- Descendant · 2 generations on · 1 of its ownK230899 qXR-PTX-PEQure.Ai Technologies · 2023
- Descendant · 2 generations on · 0 of its ownK253751 CXRDetectAINeurocareai, Inc. (Dba Savelife.Ai) · 2026
- Descendant · 2 generations on · 0 of its ownK243808 Rayvolve PTX-PEAZmed · 2025
- Descendant · 3 generations on · 0 of its ownK241439 VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link TriageVuno, Inc. · 2024
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K211733Lunit INSIGHT CXR TriageLunit, Inc. · 2021 · cites it directly7descendants
- K230899qXR-PTX-PEQure.Ai Technologies · 2023 · 2 generations on1descendant
- K253751CXRDetectAINeurocareai, Inc. (Dba Savelife.Ai) · 2026 · 2 generations on0descendants
- K243808Rayvolve PTX-PEAZmed · 2025 · 2 generations on0descendants
- K241439VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link TriageVuno, Inc. · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN170073 | ContaCT | Viz.Al, Inc. | 2018 | — |
| −2 | K183285 | cmTriage | Curemetrix, Inc. | 2019 | — |
| −1 | K190362 | HealthPNX | Zebra Medical Vision, Ltd. | 2019 | — |
| 0 (this device) | K183182 | Critical Care Suite | Ge Medical Systems, LLC | 2019 | — |
| +1 | K211733 | Lunit INSIGHT CXR Triage | Lunit, Inc. | 2021 | — |
| +2 | K230899 | qXR-PTX-PE | Qure.Ai Technologies | 2023 | — |
| +2 | K253751 | CXRDetectAI | Neurocareai, Inc. (Dba Savelife.Ai) | 2026 | — |
| +2 | K243808 | Rayvolve PTX-PE | AZmed | 2025 | — |
| +3 | K241439 | VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage | Vuno, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 QFM? 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 QFM device
- #1 K211733 Lunit INSIGHT CXR Triagescore 21.2 · 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 |
|---|---|---|---|
| * | K190362 | HealthPNX Cleared while this submission was under review Summary page 4…d Triage and Notification Software, Names: 21 CFR 892.2080 QFM Product Code: Predicate HealthPNX by Zebra Medical Vision, K190362 Device(s): Class II, 21 CFR 892.2080, Product code: QFM… | 2019 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211733 | Lunit INSIGHT CXR Triage | 2021 | 7 |
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 1 year and passes through 4 companies; a new generation was cleared every 3 months on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K211733 (Lunit, Inc., 2021) has gone furthest, with 7 descendants of its own.
- 5 other devices also cite its predicate K190362.
How does its category compare?
All QFM devicesQFM Radiological Computer-Assisted Prioritization Software For Lesions: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · QFM
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QFM
100in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QFM
No recall names QFM since 2007.
Adverse event reports per year · QFM
No MAUDE report names QFM 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 | 0 | — | 0 | 0 |
| 2019 | 4 | 97 | 0 | 0 |
| 2020 | 4 | 172 | 0 | 0 |
| 2021 | 5 | 187 | 0 | 0 |
| 2022 | 9 | 121 | 0 | 0 |
| 2023 | 8 | 206 | 0 | 0 |
| 2024 | 6 | 192 | 0 | 0 |
| 2025 | 3 | 100 | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Critical Care Suite is a computer aided triage and notification device that analyzes frontal chest x-ray images for the presence of prespecified critical findings (pneumothorax). Critical Care Suite identifies images with critical findings to enable case prioritization or triage in the PACS/workstation. Critical Care Suite is intended for notification only and does not provide diagnostic information beyond the notification. Critical Care Suite should not…
Read the full statement (105 words)
Critical Care Suite is a computer aided triage and notification device that analyzes frontal chest x-ray images for the presence of prespecified critical findings (pneumothorax). Critical Care Suite identifies images with critical findings to enable case prioritization or triage in the PACS/workstation.
Critical Care Suite is intended for notification only and does not provide diagnostic information beyond the notification. 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 adult-size patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183182 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183182: 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/K183182
Report an extraction error
Are you the manufacturer?
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