510(k) · Cleared
ClearedGarion Image-Intensified Fluoroscopic X-Ray System, Mobile
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sg Healthcare Co, Ltd. · OWB Interventional Fluoroscopic X-Ray System
Cleared on Oct 6, 2022 as substantially equivalent to K183040 (Philips Medical Systems Nederland B.V., 2018) after an 83-day review. Its family tree reaches back 6 generations to 2004. 1 later device descends from it.
- Decided
- Oct 6, 2022
- Review
- 83 days
- Class
- Class II
- Product code
- OWB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K042646 (2004). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK042646 DynactSiemens Medical Systems, Inc. · 2004
- 5 generations backK061685 PulseraPhilips Medical Systems North America Co. · 2006
- 4 generations backK090590 Veradius, Model 718-130Philips Medical Systems North America Co. · 2009
- 3 generations backK133819 VeradiusPhilips Medical Systems Nederland B.V. · 2014
- 2 generations backK142708 Veradius UnityPhilips Medical Systems Nethrlands BV · 2014 · Recalled
- 1 generation backK183040 Zenition 70Philips Medical Systems Nederland B.V. · 2018 · Recalled
- This deviceK222080 Garion Image-Intensified Fluoroscopic X-Ray System, MobileSg Healthcare Co, Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK243411 Diagnostic X-ray SystemNanjing Perlove Medical Equipment Co., Ltd. · 2025
Most influential descendants
Showing 1 of 1 · See all- K243411Diagnostic X-ray SystemNanjing Perlove Medical Equipment Co., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K042646 | Dynact | Siemens Medical Systems, Inc. | 2004 | — |
| −5 | K061685 | Pulsera | Philips Medical Systems North America Co. | 2006 | — |
| −4 | K090590 | Veradius, Model 718-130 | Philips Medical Systems North America Co. | 2009 | — |
| −3 | K133819 | Veradius | Philips Medical Systems Nederland B.V. | 2014 | — |
| −2 | K142708 | Veradius Unity | Philips Medical Systems Nethrlands BV | 2014 | 4 |
| −1 | K183040 | Zenition 70 | Philips Medical Systems Nederland B.V. | 2018 | 5 |
| 0 (this device) | K222080 | Garion Image-Intensified Fluoroscopic X-Ray System, Mobile | Sg Healthcare Co, Ltd. | 2022 | — |
| +1 | K243411 | Diagnostic X-ray System | Nanjing Perlove Medical Equipment Co., Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 OWB? 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 OWB device
- #1 K251602 Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6…score 18.3 · 18 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 |
|---|---|---|---|
| * | K183040 | Zenition 70Summary page 4…ation Number: 21 CFR 892.1650 Regulation Name: Image-Intensified Fluoroscopic X-Ray System Regulatory Class: II Product Code: OWB 2. Equivalent legally marketed device: K183040, Philips Medical Systems International B.V. Trade/Device Name: Zenition 70 Regulation Number: 21 CFR 892.1650 Regulation Name: Im… | 2018 |
| † | K200218 | Digiscan FDX | 2020 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243411 | Diagnostic X-ray System | 2025 | 0 |
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 18 years and passes through 5 companies; a new generation was cleared every 3.8 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K243411 (Nanjing Perlove Medical Equipment Co., Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K183040.
How does its category compare?
All OWB devicesOWB Interventional Fluoroscopic X-Ray System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · OWB
22in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OWB
148in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OWB
42so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OWB
14,008in 2025
MAUDE reports naming product code OWB, 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 | 3 | 52 | 0 | 1 |
| 2008 | 4 | 135 | 1 | 0 |
| 2009 | 9 | 99 | 0 | 0 |
| 2010 | 7 | 66 | 0 | 0 |
| 2011 | 6 | 79 | 0 | 1 |
| 2012 | 6 | 37 | 0 | 1 |
| 2013 | 11 | 119 | 10 | 27 |
| 2014 | 15 | 158 | 9 | 103 |
| 2015 | 11 | 66 | 35 | 2,134 |
| 2016 | 16 | 103 | 13 | 4,074 |
| 2017 | 20 | 76 | 13 | 1,604 |
| 2018 | 23 | 54 | 6 | 1,449 |
| 2019 | 9 | 174 | 7 | 1,558 |
| 2020 | 16 | 53 | 8 | 1,581 |
| 2021 | 24 | 60 | 31 | 1,981 |
| 2022 | 21 | 90 | 24 | 2,932 |
| 2023 | 12 | 152 | 22 | 7,604 |
| 2024 | 13 | 126 | 11 | 7,942 |
| 2025 | 22 | 148 | 30 | 14,008 |
| 2026 | 15 | 221 | 42 | — |
What is it indicated for?
The Garion is intended to be used and operated by: adequately trained, qualified and authorized health care professionals who have full understanding of the safety information and emergency procedures as well as the capabilities and functions of the device. The device is used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the device. The device is to be used in health care facilities both inside and outside the operating room, sterile as well as non-sterile environment in a variety of procedures.
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/K222080 · printed Nov 5, 2026
Cite this page
510(k) Report. “K222080: Garion Image-Intensified Fluoroscopic X-Ray System, Mobile.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K222080
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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