510(k) · Cleared
ClearedAirRay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Poskom Co., Ltd. · IZL System, X-Ray, Mobile
Cleared on Dec 20, 2022 as substantially equivalent to K182207 (Minxray, Inc., 2018) after an 88-day review. Its family tree reaches back 3 generations to 2004. 1 later device descends from it.
- Decided
- Dec 20, 2022
- Review
- 88 days
- Class
- Class II
- Product code
- IZL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K040046 (2004). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK040046 Minxray, Model HF120/60H PowerplusMinxray, Inc. · 2004
- 2 generations backK153059 HF1202H PowerPlus Portable X-ray EquipmentMinxray, Inc. · 2016
- 1 generation backK182207 TR90BHMinxray, Inc. · 2018
- This deviceK222896 AirRayPoskom Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK230581 TOPA12 Portable X-ray UnitNeuf, Inc. · 2023
Most influential descendants
Showing 1 of 1 · See all- K230581TOPA12 Portable X-ray UnitNeuf, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K040046 | Minxray, Model HF120/60H Powerplus | Minxray, Inc. | 2004 | — |
| −2 | K153059 | HF1202H PowerPlus Portable X-ray Equipment | Minxray, Inc. | 2016 | — |
| −1 | K182207 | TR90BH | Minxray, Inc. | 2018 | — |
| 0 (this device) | K222896 | AirRay | Poskom Co., Ltd. | 2022 | — |
| +1 | K230581 | TOPA12 Portable X-ray Unit | Neuf, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 IZL? 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 IZL device
- #1 K242015 TOPAZ Mobile X-ray System (Models : TOPAZ-32D…score 19.9 · 19 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 |
|---|---|---|---|
| * | K182207 | TR90BHSummary page 6…Device(s) [21 CFR 807.92(a)(3)] The identified predicate device within this submission is shown as follow; Predicate Device#1 510(k) Number: K182207 Applicant: MinXray., Inc Trade/Device Name: TR90BH Regulation Name:… | 2018 |
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 |
|---|---|---|---|
| K230581 | TOPA12 Portable X-ray Unit | 2023 | 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 2 companies; a new generation was cleared every 4.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K230581 (Neuf, Inc., 2023) has gone furthest, with 0 descendants of its own.
- 8 other devices also cite its predicate K182207.
How does its category compare?
All IZL devicesIZL System, X-Ray, Mobile: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · IZL
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IZL
153in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IZL
47in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IZL
27in 2025
MAUDE reports naming product code IZL, 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 | 30 | 7 | 16 |
| 2008 | 4 | 49 | 0 | 27 |
| 2009 | 3 | 125 | 0 | 35 |
| 2010 | 3 | 65 | 4 | 75 |
| 2011 | 6 | 66 | 6 | 118 |
| 2012 | 3 | 83 | 5 | 24 |
| 2013 | 0 | — | 10 | 17 |
| 2014 | 7 | 104 | 4 | 51 |
| 2015 | 4 | 88 | 4 | 30 |
| 2016 | 6 | 47 | 0 | 33 |
| 2017 | 7 | 45 | 0 | 35 |
| 2018 | 8 | 47 | 0 | 27 |
| 2019 | 9 | 33 | 2 | 40 |
| 2020 | 9 | 43 | 1 | 48 |
| 2021 | 13 | 48 | 0 | 47 |
| 2022 | 16 | 89 | 1 | 32 |
| 2023 | 3 | 55 | 6 | 77 |
| 2024 | 9 | 159 | 5 | 39 |
| 2025 | 11 | 153 | 47 | 27 |
| 2026 | 6 | 157 | 5 | — |
What is it indicated for?
The POSKOM Portable X-ray unit is a device that can conveniently generate X-rays for diagnosis when the patient condition is difficult to move. Mainly used by trained specialists, doctors or radiologists. Indication: The POSKOM Battery Type Portable X-ray Unit is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the body parts. The device must be used for…
Read the full statement (127 words)
The POSKOM Portable X-ray unit is a device that can conveniently generate X-rays for diagnosis when the patient condition is difficult to move. Mainly used by trained specialists, doctors or radiologists.
Indication:
The POSKOM Battery Type Portable X-ray Unit is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the body parts.
The device must be used for stand mounted diagnostic imaging of head, abdomen, or extremities.
The device must be used for stand mounted imaging of the chest.
Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.
Contraindication:
The use of X-radiation for diagnostic purposes in the following subjects is contraindicated.
- Pregnancy, especially first trimester
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222896 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222896: AirRay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222896
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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