510(k) K243556
- Device
- Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43)
- Applicant
- Iray Imaging Technology (Haining) Limited
- 510(k) number
- K243556
- Product code
- MQB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-03-18
- Date received
- 2024-11-18
- Regulation
- 892.1680
- Classification name
- Solid State X-Ray Imager (Flat Panel/Digital Imager)
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Junjie Qian
- Address
- # 2, Caohejing Rd. Haining CN 314499 314499
FDA Registration Numbers
- 8020997
- 3038614464
- 3021059265
- 3014209556
- 9615782
- 3016674851
- 2433615
- 1054713
- 3014634069
- 3001722928
- 3009077524
- 3013714596
- 3009001657
- 3002819275
- 3032116890
- 9614698
- 3004606964
- 3011347852
- 3011015597
- 3033525986
- 3006551157
- 1125622
- 3021736604
- 3011158427
- 3013599033
- 3009134655
- 9615439
- 3005778458
- 3011416394
- 3010300212
- 3023546785
- 3006013411
- 2024980
- 9617251
- 2243057
- 3005810333
- 3009048384
- 1418960
- 3011950073
- 1450503
- 2155
- 3008787461
- 9613152
- 3004063527
- 3027605321
- 3007734888
- 3016250464
- 3013679558
- 3004026651
- 3017585294
- 8030233
- 3017375271
- 3022131441
- 3015464948
- 3003202425
- 3030898585
- 3003768277
- 2424472
- 2126677
- 3006051164
- 3017944270
- 3015276088
- 3025442726
- 1052701
- 8030112
- 3007836437
- 3016256852
- 1418964
- 3006115340
- 3003314115
- 3017004860
- 9616014
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- 1064396
- 3023003446
- 3029916061
- 8021091
- 1721964
- 3009717300
- 3005406110
- 3012624817
- 3031503890
- 3004977335
- 3007065358
- 3005560996
- 1000181430
- 3015223550
- 3013186032
- 1717855
- 1317307
- 3008304180
- 3004989804
- 3004077520
- 3003528079
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- 1219183
- 3003775006
- 3015531968
- 3013501671
- 3009715136
- 3003768251
- 3011471624
- 3004485675
- 3012855798
Source Documents
Other 510(k) Records For Product Code MQB
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252911 | Lux HD 2530 detector (Lux HD 2530) | Iray Imaging Technology (Haining) Limited | 2025-10-09 |
| K250211 | Yushan X-Ray Flat Panel Detector | Innocare Optoelectronics Corp. | 2025-07-22 |
| K250665 | SKR 3000 | Konica Minolta, Inc. | 2025-06-17 |
| K243734 | Wireless/ Wired X-Ray Flat Panel Detectors | Allengers Medical Systems Limited | 2025-04-18 |
| K242770 | EXPD 114; EXPD 114G; EXPD 114P; EXPD 114PG | DRTECH Corporation | 2025-03-20 |
| K243443 | EXPD 4343N1; EXPD 4343N; EXPD 4343U1; EXPD 4343NU; EXPD 4343NP; EXPD 3643N1; EXPD 3643N; EXPD 3643U1; EXPD 3643NU; EXPD 3643NP | DRTECH Corporation | 2025-03-19 |
| K244010 | ExamVue Apex | Jpi Healthcare Co, Ltd. | 2025-02-24 |
| K243171 | Yushan X-Ray Flat Panel Detector | Innocare Optoelectronics Corp. | 2024-12-19 |
| K241319 | SKR 3000 | Konica Minolta, Inc. | 2024-11-21 |
| K241125 | VIVIX-S 1751S | Vieworks Co., Ltd. | 2024-11-15 |
| K240771 | PRORAD X-Ray Flat Panel Detector with DROC | Prognosys Medical Systems Private Limited | 2024-11-12 |
| K241346 | IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector) | Aspen Imaging Healthcare, Inc. | 2024-11-07 |
| K242394 | Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF) | Rayence Co., Ltd. | 2024-09-09 |
| K240371 | 0909FCC, 0909FCC-HS | Rayence Co., Ltd. | 2024-03-07 |
| K232082 | EXPD 4343S | DRTECH Corporation | 2024-02-13 |