510(k) · Cleared

Cleared

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

K190496510(k) TraditionalCleared Apr 24, 201955-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 Apr 24, 2019 after a 55-day review. The FDA summary names no predicate by number. 4 later devices descend from it.

Decided: Apr 24, 2019
Review: 55 days
Class: Class II
Product code: OAS
Recalls: None
Predicates: 0

4 later devices descend from it, 2 citing it directly.

This deviceK190496 hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUSCefla S.C. · 2019
Descendant · cites it directly · 1 of its ownK214084 hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUSCefla S.C. · 2022
Descendant · cites it directly · 1 of its ownK200688 hyperion X5, NewTom GO, X-RADiUS COMPACTCefla S.C. · 2020
Descendant · 2 generations on · 0 of its ownK252353 myray ProXIma X6Cefla S.C. · 2026
Descendant · 2 generations on · 0 of its ownK223794 hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUSCefla S.C. · 2023

Most influential descendants

Showing 4 of 4 · See all

K214084hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUSCefla S.C. · 2022 · cites it directly1descendant
K200688hyperion X5, NewTom GO, X-RADiUS COMPACTCefla S.C. · 2020 · cites it directly1descendant
K252353myray ProXIma X6Cefla S.C. · 2026 · 2 generations on0descendants
K223794hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUSCefla S.C. · 2023 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K190496	hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS	Cefla S.C.	2019	—
+1	K214084	hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS	Cefla S.C.	2022	—
+1	K200688	hyperion X5, NewTom GO, X-RADiUS COMPACT	Cefla S.C.	2020	—
+2	K252353	myray ProXIma X6	Cefla S.C.	2026	—
+2	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
2020	1	0
2022	1	0
2023	1	0
2026	1	0

FIG. 1 — Lineage of K190496, 2019–2026Source: 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?

The FDA summary names no predicate by number.

What descends from it? (4)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K214084	hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS	Cefla S.C.	2022	1
K200688	hyperion X5, NewTom GO, X-RADiUS COMPACT	Cefla S.C.	2020	1

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?

Of its descendants, K214084 (Cefla S.C., 2022) has gone furthest, with 1 descendant of its own.

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. 2019, 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 a digital panoramic, cephalometric and tomographic extra-oral X-ray system, 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 radiographs of jaws, parts of the skull and carpus for the purpose of cephalometric examination, when equipped with tele-radiographic…

Read the full statement (136 words)

hyperion X9 pro, NewTom Giano HR, X-RADiUS TRiO PLUS is a digital panoramic, cephalometric and tomographic extra-oral X-ray system, 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 radiographs of jaws, parts of the skull and carpus for the purpose of cephalometric examination, when equipped with tele-radiographic arm (CEPH);

(III) the production of tomographic images of the head, including the ear, nose and throat (ENT), of the dento-maxillo-facial 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 as stated in the FDA summary.

https://510kreport.com/device/K190496 · printed Nov 4, 2026

Cite this page

510(k) Report. “K190496: 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 4, 2026. https://510kreport.com/device/K190496

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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