510(k) K213529
- Device
- Focus HD 43 Detector
- Applicant
- Iray Technology Taicang , Ltd.
- 510(k) number
- K213529
- Product code
- MQB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-03-29
- Date received
- 2021-11-04
- 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
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- Junjie Qian
- Address
- # 33 Xinggang Rd., Taicang Port Economic Technological Development Zone Taicang CN 215434 215434
FDA Registration Numbers
- 9613152
- 3005810333
- 1450503
- 3007734888
- 3011347852
- 1125622
- 3029916061
- 3004485675
- 3017004860
- 3002819275
- 3027605321
- 1064396
- 8030233
- 2155
- 1418964
- 3014544225
- 3004977335
- 3011416394
- 3006051164
- 3009001657
- 8021091
- 9617251
- 3013599033
- 3021059265
- 8030112
- 3012855798
- 3023546785
- 3007065358
- 1000181430
- 1052701
- 3014209556
- 3013679558
- 3022810909
- 3009963139
- 3003769120
- 3015531968
- 3015276088
- 1418960
- 3011825597
- 3005778458
- 3017403245
- 9616014
- 3011471624
- 3033527770
- 3003314115
- 2424472
- 2024980
- 9614698
- 3013714596
- 3001722928
- 3005406110
- 2126677
- 3007836437
- 3004989804
- 3007305589
- 3006013411
- 3010300212
- 8020997
- 3003775006
- 3008787461
- 3008304180
- 3003202425
- 3004026651
- 3013688559
- 3014634069
- 3032116890
- 3011950073
- 3004606964
- 3006529712
- 2433615
- 3011015597
- 3004706313
- 1721964
- 3009717300
- 3008496839
- 3001556265
- 3017375271
- 3003768277
- 3009134655
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 |
| K243556 | Lux HD 35 Detector (Lux HD 35); Lux HD 43 Detector (Lux HD 43) | Iray Imaging Technology (Haining) Limited | 2025-03-18 |
| 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 |