510(k) K192766
- Device
- Digital Intraoral Imaging Plate System
- Applicant
- Fsusen Technology Co., Ltd
- 510(k) number
- K192766
- Product code
- MUH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-12-05
- Date received
- 2019-09-30
- Regulation
- 872.1800
- Classification name
- System, X-ray, Extraoral Source, Digital
- Medical specialty
- Dental
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- Elsa Li
- Address
- 1f, 3# Bldg., Tongfuyu Industrial Zone, Taoyuan St., Nanshan District Shenzhen CN 518055 518055
FDA Registration Numbers#
- 3014398772
- 3005843418
- 3000190675
- 3008361230
- 3029916103
- 3002807636
- 3002819275
- 3012649815
- 3006540014
- 3014544225
- 3022107311
- 8020825
- 3020117925
- 3010476612
- 3010445368
- 3012187973
- 3013651568
- 2032641
- 3009196578
- 1523530
- 3008770655
- 3007065358
- 3015509619
- 3013511605
- 9611036
- 3013779985
- 2024949
- 3010609444
- 3017403245
- 3011471624
- 3003314115
- 2424472
- 3005383085
- 2024980
- 3008313821
- 3038718579
- 3013360312
- 3005581016
- 3007538876
- 3043226252
- 3007007357
- 9615832
- 3031823608
- 8044167
- 8043962
- 1032227
- 3004706313
- 3009598746
- 3021736604
- 8030876
- 3030126955
- 3009048384
- 3005972890
- 3008252267
- 3034604691
- 3001052305
- 3012494290
- 3013186032
- 3018999255
- 3015376465
- 3010972172
- 3007515144
- 9615782
- 3023861999
- 3003528079
- 3021551875
- 1054713
- 3013503781
- 3009608361
- 3016875543
- 1226003
- 9611445
- 3010281549
- 3042046320
- 3006610845
- 3002994636
- 3014683120
- 3004765453
- 3003934980
- 3015464948
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code MUH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251793 | SOTA Cloud Smart Sensor (1.5) | Sota Cloud Corp. | 2026-03-03 |
| K252570 | EzSensor HD, EzSensor UHD | Qpix Solutions, Inc. | 2025-11-10 |
| K250687 | Cocoon Solo (DX-7020s) | Dexcowin Global, Inc. | 2025-10-24 |
| K251206 | Digital X-Ray DentiMax Pro Imaging System | Dentimax, Inc. | 2025-09-24 |
| K240040 | 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) | VATECH Co., Ltd. | 2024-10-25 |
| K242778 | X Sensor (Model: IOS-A15IF, HDI-15DGF) | Qpix Solutions, Inc. | 2024-10-11 |
| K241649 | DUO1 and DUO2 | Zinnovi, Inc. | 2024-07-05 |
| K232325 | RAYSCAN a-Expert | Ray Co., Ltd. | 2024-04-18 |
| K231660 | Digital image scanner of dental | Jiangsu Dynamic Medical Technology Co., Ltd. | 2023-12-20 |
| K233053 | DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size 2 Intraoral Sensor | Dental Imaging Technologies Corporation | 2023-11-21 |
| K232552 | TuxDeluxe (Size 1 6100B, Size 2 6101B) | Tuxedo Imaging, LLC | 2023-10-20 |
| K230998 | Digital Wireless Intraoral X-Ray Sensor | Iray Imaging Technology (Haining) Limited | 2023-10-20 |
| K230916 | WeSensor | Picopack, Inc. | 2023-10-10 |
| K232255 | EZSensor XHD | Qpix Solutions, Inc. | 2023-09-27 |
| K232158 | GenX-CR | Genoray Co., Ltd. | 2023-09-13 |
Legacy Summary#
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FDA Review#
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