510(k) · Cleared
ClearedHyperion X5
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 Dec 9, 2016 as substantially equivalent to K123381 (Cefla S.C., 2013) and 1 other predicate after a 151-day review. Its family tree reaches back 2 generations to 2013.
- Decided
- Dec 9, 2016
- Review
- 151 days
- Class
- Class II
- Product code
- OAS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K123381 (2013). 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? (2)
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 |
|---|---|---|---|
| * | K123381 | Hyperion X9Summary page 4…Product code Applicant Device name Number CEFLA S.C. HYPERION X9 K123381 OAS/ MUH CEFLA S.C. HYPERION X5 K152162 MUH… | 2013 |
| * | K152162 | Myray- HYPERION X5Summary page 4…Number CEFLA S.C. HYPERION X9 K123381 OAS/ MUH CEFLA S.C. HYPERION X5 K152162 MUH Page 1 === Page 5 =… | 2015 |
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 3 years and passes through 1 company; a new generation was cleared every 2.6 years on median.
- None of the 2 ancestors has a recall.
- 3 other devices also cite its predicate K123381.
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. 2016, 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?
The Hyperion X5 device, 3D version machine, is an image reproducer suitable for expert professionals, which allows to obtain dental images in a simple and automatic way. The image is acquired by means of an X-ray detector and a constant potential X-ray source, powered by a high-voltage and high-frequency generator. The image is then transmitted to a computer in real time. The Hyperion X5 device, 3D version machine, intended to: I. produce orthopanoramic…
Read the full statement (165 words)
The Hyperion X5 device, 3D version machine, is an image reproducer suitable for expert professionals, which allows to obtain dental images in a simple and automatic way. The image is acquired by means of an X-ray detector and a constant potential X-ray source, powered by a high-voltage and high-frequency generator. The image is then transmitted to a computer in real time.
The Hyperion X5 device, 3D version machine, intended to:
I. produce orthopanoramic images of the maxillofacial region and carry out diagnostic examination on teeth, dental arches and other structures in the oral cavity:
II. produce tomographic images of the oral cavity and maxillofacial structures and carry out diagnostic examination on teeth, dental arches, structures of the oral cavity and some cranial bones.
The system performs tomographic exams with the acquisition of X-ray images through a rotating sequence and the reconstruction of a three-dimensional matrix of the examined volume, thus producing two- and three-dimensional views of the volume itself. This technique is known as CBCT.
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/K161900 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161900: Hyperion X5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161900
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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