MQB · Solid State X-Ray Imager (Flat Panel/Digital Imager)

Device class

Class II

Regulation 892.1680

Total clearances

100

2020-01-31 → 2026-07-31

Last 12 months

Unique sponsors

Classification details

Medical specialty

Radiology

Review panel

Regulation number

892.1680

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.	12	0	2022-10-20
Canon, Inc.	11	0	2023-02-15
Rayence Co., Ltd.	8	1	2026-07-31
Lg Electronics.Inc	6	0	2023-01-27
DRTECH Corporation	6	0	2025-03-20
Vieworks Co., Ltd.	5	1	2026-06-18
Konica Minolta, Inc.	5	0	2025-06-17
Innocare Optoelectronics Corp.	5	0	2025-07-22
Carestream Health	4	0	2022-01-14
H&abyz Co., Ltd.	4	0	2023-03-06
Careray Digital Medical Technology Co., Ltd.	3	0	2023-08-03
Radmedix, LLC	3	0	2023-07-12
Careray Digital Medical System Co., Ltd.	2	0	2021-02-19
Iray Imaging Technology (Haining) Limited	2	1	2025-10-09
Allengers Medical Systems Limited	2	0	2025-04-18
Agfa N.V.	2	0	2021-11-18
Konica Minolta Healthcare Americas, Inc.	2	1	2026-06-12
Astel, Inc.	1	0	2021-08-25
First Source, Inc.	1	0	2021-03-24
Jpi Healthcare Co, Ltd.	1	0	2025-02-24
Ray Imaging Technology (Haining) Limited	1	0	2023-02-03
Livermoretech, Inc.	1	0	2020-02-14
Osko, Inc.	1	0	2020-06-29
Philips Medical Systems Dmc GmbH	1	0	2020-09-30
Prognosys Medical Systems Private Limited	1	0	2024-11-12

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
71046	CPT	—	Medium	X-ray, chest; 3-view
76080	CPT	—	Medium	Imaging, plain film; fluoroscopic

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-07-31	K253800	Rayence Co., Ltd.	0909FCE, 0909FCE-HS
2026-06-18	K260820	Vieworks Co., Ltd.	VIVIX-S 4386W (FXRD-4386WA)
2026-06-12	K252996	Konica Minolta Healthcare Americas, Inc.	Universal 1417PI
2025-10-09	K252911	Iray Imaging Technology (Haining) Limited	Lux HD 2530 detector (Lux HD 2530)
2025-07-22	K250211	Innocare Optoelectronics Corp.	Yushan X-Ray Flat Panel Detector
2025-06-17	K250665	Konica Minolta, Inc.	SKR 3000
2025-04-18	K243734	Allengers Medical Systems Limited	Wireless/ Wired X-Ray Flat Panel Detectors
2025-03-20	K242770	DRTECH Corporation	EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG
2025-03-19	K243443	DRTECH Corporation	EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXPD 3643N; EXPD 3643U1; EXPD 3643NU; EXPD 3643NP
2025-03-18	K243556	Iray Imaging Technology (Haining) Limited	Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43)
2025-02-24	K244010	Jpi Healthcare Co, Ltd.	ExamVue Apex
2024-12-19	K243171	Innocare Optoelectronics Corp.	Yushan X-Ray Flat Panel Detector
2024-11-21	K241319	Konica Minolta, Inc.	SKR 3000
2024-11-15	K241125	Vieworks Co., Ltd.	VIVIX-S 1751S
2024-11-12	K240771	Prognosys Medical Systems Private Limited	PRORAD X-Ray Flat Panel Detector with DROC
2024-11-07	K241346	Aspen Imaging Healthcare, Inc.	IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector)
2024-09-09	K242394	Rayence Co., Ltd.	Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF)
2024-03-07	K240371	Rayence Co., Ltd.	0909FCC, 0909FCC-HS
2024-02-13	K232082	DRTECH Corporation	EXPD 4343S
2023-11-16	K232753	DRTECH Corporation	EXPD 4343D; EXPD 3643D
2023-09-01	K230918	Medicatech USA	MasterX 800 Series
2023-08-03	K232058	Careray Digital Medical Technology Co., Ltd.	YosemiteView 4343W/YosemiteView 3643W
2023-08-01	K231959	DRTECH Corporation	EXPD 4357; EXPD 4357P
2023-07-12	K231709	Radmedix, LLC	AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4
2023-06-21	K231467	Rayence Co., Ltd.	1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF