510(k) · Cleared
ClearedHF1202H PowerPlus Portable X-ray Equipment
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Minxray, Inc. · IZL System, X-Ray, Mobile
Cleared on Feb 2, 2016 as substantially equivalent to K040046 (Minxray, Inc., 2004) after a 104-day review. Its family tree reaches back 1 generation to 2004. 17 later devices descend from it.
- Decided
- Feb 2, 2016
- Review
- 104 days
- Class
- Class II
- Product code
- IZL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K040046 (2004). 17 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK040046 Minxray, Model HF120/60H PowerplusMinxray, Inc. · 2004
- This deviceK153059 HF1202H PowerPlus Portable X-ray EquipmentMinxray, Inc. · 2016
- Descendant · cites it directly · 16 of its ownK182207 TR90BHMinxray, Inc. · 2018
- Descendant · 2 generations on · 3 of its ownK212144 Remex KA6Remedi Co., Ltd. · 2021
- Descendant · 2 generations on · 1 of its ownK222896 AirRayPoskom Co., Ltd. · 2022
- Descendant · 2 generations on · 1 of its ownK210479 IMPACT and X-RangerMinxray, Inc. · 2021
- Descendant · 2 generations on · 1 of its ownK200637 SR-8100 Portable X-ray UnitShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) · 2020
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K182207TR90BHMinxray, Inc. · 2018 · cites it directly16descendants
- K212144Remex KA6Remedi Co., Ltd. · 2021 · 2 generations on3descendants
- K222896AirRayPoskom Co., Ltd. · 2022 · 2 generations on1descendant
- K210479IMPACT and X-RangerMinxray, Inc. · 2021 · 2 generations on1descendant
- K200637SR-8100 Portable X-ray UnitShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) · 2020 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K040046 | Minxray, Model HF120/60H Powerplus | Minxray, Inc. | 2004 | — |
| 0 (this device) | K153059 | HF1202H PowerPlus Portable X-ray Equipment | Minxray, Inc. | 2016 | — |
| +1 | K182207 | TR90BH | Minxray, Inc. | 2018 | — |
| +2 | K212144 | Remex KA6 | Remedi Co., Ltd. | 2021 | — |
| +2 | K222896 | AirRay | Poskom Co., Ltd. | 2022 | — |
| +2 | K210479 | IMPACT and X-Ranger | Minxray, Inc. | 2021 | — |
| +2 | K200637 | SR-8100 Portable X-ray Unit | Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 6 | 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 |
|---|---|---|---|
| * | K040046 | Minxray, Model HF120/60H PowerplusSummary page 4…ation Name: Mobile x-ray system, Product Code IZL Regulation Number 892.1720 Common/Usual Name: Mobile Diagnostic X-Ray System 3. Equivalent legally marketed device: K040046, MinXray HF120/60 PowerPlus,™ made by Mikasa X-Ray Co. Ltd. (for MinXray). Mobile x-ray system, Product Code IZL Regulation Nu… | 2004 |
What descends from it? (17)
See all 171 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182207 | TR90BH | 2018 | 16 |
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?
How does its category compare?
All IZL devicesIZL System, X-Ray, Mobile: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
This radiographic system is intended for use by a qualified/trained physician or technician on both adult and pediatric subjects for taking diagnostic x-rays. Not for mammographic use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153059 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153059: HF1202H PowerPlus Portable X-ray Equipment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153059
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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