510(k) · Cleared
Clearedmyray ProXIma X6
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cefla S.C. · OAS X-Ray, Tomography, Computed, Dental
Cleared on Mar 10, 2026 as substantially equivalent to K200688 (Cefla S.C., 2020) after a 224-day review. Its family tree reaches back 2 generations to 2019.
- Decided
- Mar 10, 2026
- Review
- 224 days
- Class
- Class II
- Product code
- OAS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K190496 (2019). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 OAS? 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 OAS device
- #1 K213226 RCT700score 18.0 · 13 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 |
|---|---|---|---|
| * | K200688 | hyperion X5, NewTom GO, X-RADiUS COMPACTSummary page 6…marketed by the CEFLA and considered as predicate and reference devices. ProXIma X6 predicate device is hyperion X5 already cleared by the Agency in K200688. Compared to the reference device Hyperion X9 Pro, ProXIma X6 is not able to perform otorhinolaryngologic… | 2020 |
| † | K223794 | hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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 7 years and passes through 1 company; a new generation was cleared every 5.9 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All OAS devicesOAS X-Ray, Tomography, Computed, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · OAS
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OAS
144in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OAS
3in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OAS
1in 2025
MAUDE reports naming product code OAS, 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 | 2 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 6 | 168 | 0 | 0 |
| 2012 | 7 | 110 | 0 | 0 |
| 2013 | 10 | 155 | 0 | 0 |
| 2014 | 5 | 170 | 0 | 0 |
| 2015 | 5 | 164 | 1 | 0 |
| 2016 | 12 | 154 | 0 | 0 |
| 2017 | 4 | 209 | 0 | 0 |
| 2018 | 11 | 57 | 0 | 0 |
| 2019 | 7 | 55 | 0 | 1 |
| 2020 | 9 | 113 | 0 | 0 |
| 2021 | 11 | 92 | 0 | 0 |
| 2022 | 6 | 105 | 0 | 1 |
| 2023 | 12 | 77 | 0 | 1 |
| 2024 | 4 | 129 | 0 | 2 |
| 2025 | 9 | 144 | 3 | 1 |
| 2026 | 9 | 77 | 0 | — |
What is it indicated for?
ProXIma X6 is an extra-oral X-ray equipment for digital panoramic, tomographic and cephalometric Xrays exams, indicated for the following: (I) production of orthopanoramic images of the maxillofacial area, diagnostic dental exams on teeth, dental arches and other structures of the oral cavity; (II) Production of X-ray images of the dental arches, parts of the cranium and of the carpus in support of cephalometric examination, where the configuration…
Read the full statement (123 words)
ProXIma X6 is an extra-oral X-ray equipment for digital panoramic, tomographic and cephalometric Xrays exams, indicated for the following:
(I) production of orthopanoramic images of the maxillofacial area, diagnostic dental exams on teeth, dental arches and other structures of the oral cavity;
(II) Production of X-ray images of the dental arches, parts of the cranium and of the carpus in support of cephalometric examination, where the configuration includes the CEPH arm;
(III) production of tomographic images of the structures of the maxillofacial area and oral cavity for diagnostic dental exams on teeth, dental arches, the structures of the oral cavity, where the configuration includes the CBCT option.
The device is operated and used by physicians, dentists, x-ray technologists and other legally qualified professionals.
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/K252353 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252353: myray ProXIma X6.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252353
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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