MUH · System, X-Ray, Extraoral Source, Digital

Device class

Class II

Regulation 872.1800

Total clearances

2020-02-20 → 2026-03-03

Last 12 months

Unique sponsors

Classification details

Medical specialty

Dental

Review panel

Regulation number

872.1800

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Iray Technology Taicang , Ltd.	3	0	2022-03-11
Qpix Solutions, Inc.	3	1	2025-11-10
Genoray Co., Ltd.	2	0	2023-09-13
Iray Imaging Technology (Haining) Limited	2	0	2023-10-20
Durr Dental SE	2	0	2023-02-06
Dentimax, Inc.	2	0	2025-09-24
Fona S.R.L	1	0	2021-08-30
Dürr Dental SE	1	0	2020-10-07
Tuxedo Imaging, LLC	1	0	2023-10-20
Sota Cloud Corp.	1	1	2026-03-03
Jiangsu Dynamic Medical Technology Co., Ltd.	1	0	2023-12-20
Guilin Woodpecker Medical Instrument Co., Ltd.	1	0	2021-09-27
Picopack, Inc.	1	0	2023-10-10
Denterprise International, Inc.	1	0	2023-06-22
Remedi Co., Ltd.	1	0	2020-02-28
Sota Precision Optics, Inc. Dba Sota Imaging	1	0	2020-11-06
Athlos OY	1	0	2021-07-22
Rolence Enterprise, Inc.	1	0	2021-09-15
Shenzhen Xpectvision Technology Co., Ltd.	1	0	2022-02-17
De Gotzen S.R.L.	1	0	2020-02-20
Zinnovi, Inc.	1	0	2024-07-05
Trident S.R.L	1	0	2020-04-15
VATECH Co., Ltd.	1	0	2024-10-25
Realcloud Imaging Inc. Dba Realcloud Imaging	1	0	2022-08-31
Dexcowin Global, Inc.	1	1	2025-10-24

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
70450	CPT	—	Medium	CPT for head/neck CT or radiographic imaging depending on system type
D0210	HCPCS	—	Medium	CDT code for intraoral/extraoral digital radiography

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-03-03	K251793	Sota Cloud Corp.	SOTA Cloud Smart Sensor (1.5)
2025-11-10	K252570	Qpix Solutions, Inc.	EzSensor HD, EzSensor UHD
2025-10-24	K250687	Dexcowin Global, Inc.	Cocoon Solo (DX-7020s)
2025-09-24	K251206	Dentimax, Inc.	Digital X-Ray DentiMax Pro Imaging System
2024-10-25	K240040	VATECH Co., Ltd.	VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan)
2024-10-11	K242778	Qpix Solutions, Inc.	X Sensor (Model: IOS-A15IF, HDI-15DGF)
2024-07-05	K241649	Zinnovi, Inc.	DUO1 and DUO2
2024-04-18	K232325	Ray Co., Ltd.	RAYSCAN a-Expert
2023-12-20	K231660	Jiangsu Dynamic Medical Technology Co., Ltd.	Digital image scanner of dental
2023-11-21	K233053	Dental Imaging Technologies Corporation	DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size 2 Intraoral Sensor
2023-10-20	K232552	Tuxedo Imaging, LLC	TuxDeluxe (Size 1 6100B, Size 2 6101B)
2023-10-20	K230998	Iray Imaging Technology (Haining) Limited	Digital Wireless Intraoral X-Ray Sensor
2023-10-10	K230916	Picopack, Inc.	WeSensor
2023-09-27	K232255	Qpix Solutions, Inc.	EZSensor XHD
2023-09-13	K232158	Genoray Co., Ltd.	GenX-CR
2023-06-22	K231202	Denterprise International, Inc.	QuickRayPRO
2023-04-21	K230811	Iray Imaging Technology (Haining) Limited	Digital Intraoral X-Ray Sensor
2023-04-11	K230732	Alliage S/A Industrias Medica Odontológico.	Eagle S/Saevo Slim/D700 Slim
2023-02-06	K230095	Durr Dental SE	ScanX Swift 2.0, ScanX Swift View 2.0
2022-08-31	K221955	Realcloud Imaging Inc. Dba Realcloud Imaging	Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20
2022-06-22	K221008	Shanghai Handy Medical Equipment Co., Ltd.	HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2)
2022-05-19	K220423	Genoray Co., Ltd.	PAPAYA & PAPAYA Plus
2022-04-13	K220556	Dentimax, Inc.	OpenSensorX Series
2022-03-11	K220422	Iray Technology Taicang , Ltd.	Dental sensors NanoPix1, NanoPix2
2022-03-02	K214091	Hefei Dentafilm Medical Equipment Co., Ltd.	Dental Image Plate Scanner, Model DFC-4T-SMART