510(k) · Cleared

Cleared

hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS

K214084510(k) SpecialCleared Jan 20, 202224-day reviewClass II21 CFR 892.1750

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cefla S.C. · OAS X-Ray, Tomography, Computed, Dental

Cleared on Jan 20, 2022 as substantially equivalent to K190496 (Cefla S.C., 2019) after a 24-day review. Its family tree reaches back 1 generation to 2019. 1 later device descends from it.

Decided: Jan 20, 2022
Review: 24 days
Class: Class II
Product code: OAS
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K190496 (2019). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK190496 hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUSCefla S.C. · 2019
This deviceK214084 hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUSCefla S.C. · 2022
Descendant · cites it directly · 0 of its ownK223794 hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUSCefla S.C. · 2023

Most influential descendants

Showing 1 of 1 · See all

K223794hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUSCefla S.C. · 2023 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K190496	hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS	Cefla S.C.	2019	—
0 (this device)	K214084	hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS	Cefla S.C.	2022	—
+1	K223794	hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS	Cefla S.C.	2023	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2023	1	0

FIG. 1 — Lineage of K214084, 2019–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K190496	hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS Summary page 4 …omographic radiological system developed and manufactured by CEFLA S.C. The proposed device is a change of the predicate device: hyperion X9 pro (K190496). Like the predicate device the proposed device can be sold under three different proprietary product nam…	Cefla S.C.	2019	—

Also cleared against K190496: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K223794	hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS	Cefla S.C.	2023	0

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?

Its one ancestor has no recall.
Of its descendants, K223794 (Cefla S.C., 2023) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K190496.

How does its category compare?

All OAS devices

OAS X-Ray, Tomography, Computed, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.

FDA decisions per year · OAS

9in 2025

2007high 12 (2016) · low 1 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OAS

144in 2025

2007high 209 (2017) · low 55 (2019)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · OAS

3in 2025

2007high 3 (2025) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · OAS

1in 2025

2007high 2 (2024) · low 0 (2007)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?

hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS is digital panoramic, cephalometric and tomographic extra-oral system, intended to: () 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 radiographs of jaws, parts of the skull and carpus for the purpose of cephalometric examination, if equipped with tele-radiographic arm (CEPH)…

Read the full statement (134 words)

hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS is digital panoramic, cephalometric and tomographic extra-oral system, intended to:

() 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 radiographs of jaws, parts of the skull and carpus for the purpose of cephalometric examination, if equipped with tele-radiographic arm (CEPH);

(II1) the production of tomographic images of the head, including the ear, nose and throat (ENT), of the dento-maxillofacial complex, teeth, mandible and maxilla, temporomandibular-articular joint (TMJ), other areas of the human skull and neck with sections of the cervical spine for use in diagnostic support, if equipped with 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/K214084 · printed Nov 6, 2026

Cite this page

510(k) Report. “K214084: hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K214084

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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