Chrysalis Intelligence · Product Codes · MQB

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

Radiology · 100 clearances · 35 unique sponsors

Device class
Class II
Regulation 892.1680
Total clearances
100
2020-01-31 → 2026-07-31
Last 12 months
4
Unique sponsors
35
Medical specialty
Radiology
Review panel
RA
Regulation number
892.1680
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
Y
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
H&abyz Co., Ltd. 4 0 2023-03-06
Carestream Health 4 0 2022-01-14
Careray Digital Medical Technology Co., Ltd. 3 0 2023-08-03
Radmedix, LLC 3 0 2023-07-12
Agfa N.V. 2 0 2021-11-18
Konica Minolta Healthcare Americas, Inc. 2 1 2026-06-12
Careray Digital Medical System Co., Ltd. 2 0 2021-02-19
Allengers Medical Systems Limited 2 0 2025-04-18
Iray Imaging Technology (Haining) Limited 2 1 2025-10-09
Philips Medical Systems Dmc GmbH 1 0 2020-09-30
First Source, Inc. 1 0 2021-03-24
A.T.S. Applicazione Tecnologie Speciali S.R.L. 1 0 2021-07-09
Dentium Co., Ltd (Ict Branch) 1 0 2020-06-10
Jpi Healthcare Co, Ltd. 1 0 2025-02-24
Livermoretech, Inc. 1 0 2020-02-14
Prognosys Medical Systems Private Limited 1 0 2024-11-12
Osko, Inc. 1 0 2020-06-29
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.

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

Most recent 510(k) clearances

DateK-numberSponsorDevice
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