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

Q: What is the product code of K223794?

The FDA product code is OAS – X-Ray, Tomography, Computed, Dental, a Class II (moderate risk) device regulated under 21 CFR 892.1750.

FDA 510(k) K223794 · Cefla S.C.

Substantially Equivalent

510(k) numberK223794

Submission

Device name: hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS
Applicant: Cefla S.C.
Imola (Bo), IT
Received: December 19, 2022
Decision date: January 17, 2023
Decision: Substantially Equivalent (SESE)
Type: Special 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: OAS – X-Ray, Tomography, Computed, Dental
Device class: Class II (moderate risk)
Regulation: 21 CFR 892.1750
Specialty: Radiology

Produce cross-sectional diagnostic x-ray images of the intra-oral tissue and teeth.

Other 510(k)s with product code OAS

510(k)	Device	Applicant	Decision
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K250839	Dental X-ray SystemOAS · Traditional	Changzhou Boen Zhongding Medical Technology Co.…	06/11/2026SE
K260662	Dental Cone Beam Computed Tomography SystemOAS · Special	Yofo Medical Technology Co., Ltd.	06/04/2026SE
K253935	medXion NEXUSOAS · Traditional	medXion Technologies, Inc.	05/15/2026SE
K260462	RCT800OAS · Special	Ray Co., Ltd.	04/09/2026SE
K260093	Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)OAS · Special	VATECH Co., Ltd.	03/31/2026SE
K252353	myray ProXIma X6OAS · Traditional	Cefla S.C.	03/10/2026SE
K253959	Primevision 3DOAS · Traditional	Dentsply Sirona	02/05/2026SE
K251798	RCT700OAS · Traditional	Ray Co., Ltd.	11/25/2025SE
K251842	Dental Computed Tomography X-ray SystemOAS · Traditional	Fussen Technology Co., Ltd.	11/13/2025SE

More from Fussen Technology Co., Ltd.

510(k)	Device	Decision
K260716	NeowiseLLZ · Traditional	05/04/2026SE
K252353	myray ProXIma X6OAS · Traditional	03/10/2026SE
K230895	CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs FLUO; i-XR3, i-XR3…EBW · Traditional	04/01/2024SE
K231990	Apex LocatorLQY · Traditional	02/13/2024SE
K213022	CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER…EBW · Traditional	05/09/2022SE
K220664	NewTom 7GJAK · Traditional	05/06/2022SE
K214084	hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUSOAS · Special	01/20/2022SE
K200688	hyperion X5, NewTom GO, X-RADiUS COMPACTOAS · Traditional	04/09/2020SE
K190496	hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUSOAS · Traditional	04/24/2019SE
K183448	NewTom 5G XLJAK · Traditional	03/08/2019SE

Questions and answers

When was hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS cleared by the FDA?

hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS (K223794) received a 510(k) decision of Substantially Equivalent on January 17, 2023, 29 days after the submission was received.

What is the product code of K223794?

The FDA product code is OAS – X-Ray, Tomography, Computed, Dental, a Class II (moderate risk) device regulated under 21 CFR 892.1750.