510(k) · Cleared
ClearedTR90BH
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 Dec 14, 2018 as substantially equivalent to K153059 (Minxray, Inc., 2016) after a 121-day review. Its family tree reaches back 2 generations to 2004. 16 later devices descend from it.
- Decided
- Dec 14, 2018
- Review
- 121 days
- Class
- Class II
- Product code
- IZL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K040046 (2004). 16 later devices descend from it, 9 citing it directly.
- Root · 2 generations backK040046 Minxray, Model HF120/60H PowerplusMinxray, Inc. · 2004
- 1 generation backK153059 HF1202H PowerPlus Portable X-ray EquipmentMinxray, Inc. · 2016
- This deviceK182207 TR90BHMinxray, Inc. · 2018
- Descendant · cites it directly · 3 of its ownK212144 Remex KA6Remedi Co., Ltd. · 2021
- Descendant · cites it directly · 1 of its ownK222896 AirRayPoskom Co., Ltd. · 2022
- Descendant · cites it directly · 1 of its ownK210479 IMPACT and X-RangerMinxray, Inc. · 2021
- Descendant · cites it directly · 1 of its ownK200637 SR-8100 Portable X-ray UnitShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) · 2020
- Descendant · cites it directly · 1 of its ownK200976 SR-8230, SR-8230S Portable X-ray UnitShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) · 2020
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K212144Remex KA6Remedi Co., Ltd. · 2021 · cites it directly3descendants
- K222896AirRayPoskom Co., Ltd. · 2022 · cites it directly1descendant
- K210479IMPACT and X-RangerMinxray, Inc. · 2021 · cites it directly1descendant
- K200637SR-8100 Portable X-ray UnitShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) · 2020 · cites it directly1descendant
- K200976SR-8230, SR-8230S Portable X-ray UnitShantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) · 2020 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K040046 | Minxray, Model HF120/60H Powerplus | Minxray, Inc. | 2004 | — |
| −1 | K153059 | HF1202H PowerPlus Portable X-ray Equipment | Minxray, Inc. | 2016 | — |
| 0 (this device) | K182207 | TR90BH | Minxray, Inc. | 2018 | — |
| +1 | K212144 | Remex KA6 | Remedi Co., Ltd. | 2021 | — |
| +1 | K222896 | AirRay | Poskom Co., Ltd. | 2022 | — |
| +1 | K210479 | IMPACT and X-Ranger | Minxray, Inc. | 2021 | — |
| +1 | K200637 | SR-8100 Portable X-ray Unit | Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) | 2020 | — |
| +1 | K200976 | SR-8230, SR-8230S 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K153059 | HF1202H PowerPlus Portable X-ray EquipmentSummary page 4…ation Name: Mobile X-Ray System Regulatory Class: II Product Code: IZL Common/Usual Name: Mobile Diagnostic X-Ray System 2. Equivalent legally marketed device: K153059 Trade/Device Name: HF1202H PowerPlus™ Portable X-Ray Equipment Manufacturer: MinXray, Inc. Regulation Number: 21CFR892.1… | 2016 |
| † | K945707 | Minxray HF80H High Frequency Diagnostic X-Ray Unit | 1995 |
What descends from it? (16)
See all 169 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 14 years and passes through 1 company; a new generation was cleared every 12.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K212144 (Remedi Co., Ltd., 2021) has gone furthest, with 3 descendants of its own.
How does its category compare?
All IZL devicesIZL System, X-Ray, Mobile: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 TR90BH is a portable X-ray system with following limitations of use: The device may be used for handheld diagnostic imaging of body extremities
The device may be used for stand mounted diagnostic imaging of head, abdomen, or extremities.
The device may be used for stand mounted imaging of the chest when used without a grid.
- Not to be used on bariatric patients, unless imaging body extremities
- Not for mammography use
- The TR90BH is not intended to replace a stationary radiographic system, which may be required for full optimization of image quality and radiation exposure for different exam types.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182207 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182207: TR90BH.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182207
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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