510(k) · Cleared
ClearedRextar X
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meta Biomed, Inc. · EHD Unit, X-Ray, Extraoral With Timer
Cleared on Jul 31, 2013 as substantially equivalent to K122016 (Meta Biomed, Inc., 2013) after a 29-day review. Its family tree reaches back 6 generations to 2000. 7 later devices descend from it.
- Decided
- Jul 31, 2013
- Review
- 29 days
- Class
- Class II
- Product code
- EHD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K000061 (2000). 7 later devices descend from it, 6 citing it directly.
- Root · 6 generations backK000061 Minxray HF70D High Frequency Portable Dental X-Ray UnitMinxray, Inc. · 2000
- 5 generations backK021378 Portable HDX Intraoral X-RayDentalez Group · 2002 · Recalled
- 4 generations backK051795 Nomad Dental X-Ray SystemAribex, Inc. · 2005
- 3 generations backK063121 Portable X-Ray System, Model Port-X IIGenoray Co., Ltd. · 2007
- 2 generations backK082167 Portable X-Ray System, Models Diox-602, ProxDigimed Corporation · 2008 · Recalled
- 1 generation backK122016 Rextar, Rextar LCDMeta Biomed, Inc. · 2013
- This deviceK132041 Rextar XMeta Biomed, Inc. · 2013
- Descendant · cites it directly · 1 of its ownK172810 Port-X IVGenoray Co., Ltd. · 2018
- Descendant · cites it directly · 0 of its ownK242185 Rextar ProRaypia Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK221587 DHX-70H, XTG-70HDigimed Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK223010 Portable X-ray SystemIray Technology Taicang, Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK220579 Hybrid C70Digimed Co., Ltd. · 2022
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K172810Port-X IVGenoray Co., Ltd. · 2018 · cites it directly1descendant
- K242185Rextar ProRaypia Co., Ltd. · 2024 · cites it directly0descendants
- K221587DHX-70H, XTG-70HDigimed Co., Ltd. · 2023 · cites it directly0descendants
- K223010Portable X-ray SystemIray Technology Taicang, Ltd. · 2023 · 2 generations on0descendants
- K220579Hybrid C70Digimed Co., Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K000061 | Minxray HF70D High Frequency Portable Dental X-Ray Unit | Minxray, Inc. | 2000 | — |
| −5 | K021378 | Portable HDX Intraoral X-Ray | Dentalez Group | 2002 | 1 |
| −4 | K051795 | Nomad Dental X-Ray System | Aribex, Inc. | 2005 | — |
| −3 | K063121 | Portable X-Ray System, Model Port-X II | Genoray Co., Ltd. | 2007 | — |
| −2 | K082167 | Portable X-Ray System, Models Diox-602, Prox | Digimed Corporation | 2008 | 1 |
| −1 | K122016 | Rextar, Rextar LCD | Meta Biomed, Inc. | 2013 | — |
| 0 (this device) | K132041 | Rextar X | Meta Biomed, Inc. | 2013 | — |
| +1 | K172810 | Port-X IV | Genoray Co., Ltd. | 2018 | — |
| +1 | K242185 | Rextar Pro | Raypia Co., Ltd. | 2024 | — |
| +1 | K221587 | DHX-70H, XTG-70H | Digimed Co., Ltd. | 2023 | — |
| +2 | K223010 | Portable X-ray System | Iray Technology Taicang, Ltd. | 2023 | — |
| +1 | K220579 | Hybrid C70 | Digimed Co., Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 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 EHD? 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 EHD device
- #1 K260795 Hand-held Dental X-ray System (HyperLight-M)score 14.1 · 8 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 |
|---|---|---|---|
| * | K122016 | Rextar, Rextar LCDSummary page 2…Manufacturer : Poskom Co. Ltd. Device : Rextar LCD 510(k) Number: K1 22016 (Decision Date - 03/01/2013) 7. Classifications Names & Citations:… | 2013 |
What descends from it? (7)
6 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 13 years and passes through 6 companies; a new generation was cleared every 2.2 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K172810 (Genoray Co., Ltd., 2018) has gone furthest, with 1 descendant of its own.
How does its category compare?
All EHD devicesEHD Unit, X-Ray, Extraoral With Timer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · EHD
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EHD
58in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EHD
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EHD
6in 2024
MAUDE reports naming product code EHD, 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 | 1 | — | 0 | 5 |
| 2008 | 5 | 49 | 0 | 6 |
| 2009 | 4 | 92 | 0 | 38 |
| 2010 | 4 | 268 | 3 | 47 |
| 2011 | 3 | 102 | 3 | 26 |
| 2012 | 2 | — | 0 | 22 |
| 2013 | 4 | 216 | 0 | 21 |
| 2014 | 3 | 107 | 1 | 20 |
| 2015 | 1 | — | 0 | 110 |
| 2016 | 2 | — | 1 | 63 |
| 2017 | 4 | 28 | 1 | 66 |
| 2018 | 5 | 30 | 0 | 21 |
| 2019 | 4 | 173 | 0 | 21 |
| 2020 | 2 | — | 0 | 4 |
| 2021 | 1 | — | 0 | 4 |
| 2022 | 8 | 58 | 0 | 4 |
| 2023 | 8 | 147 | 0 | 2 |
| 2024 | 7 | 58 | 0 | 6 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 6 | 128 | 0 | — |
What is it indicated for?
REXTAR X is to be used by trained dentists and dental technicians as a mobile, extraoral x-ray source for producing diagnostic x-ray images using intraoral image receptors. It is intended for both adult and pediatric subjects.
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/K132041 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132041: Rextar X.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132041
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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