Radiance
Radiance Ultra 32", Digital Secondary, Custom Depuy Synthes, Brazil, SC-WU32-G1520
22manufacturers in China registered for this device type
129catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (10), Guangdong (5), Shanghai (4). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dentall, Inc. | District | Beijing | Contract manufacturer | 13 |
| Qisda Electronics (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 5 |
| Barco (Suzhou) Healthcare Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 4 |
| Coretronic Projection (Kunshan) Corporation | Kunshan | Jiangsu | Contract manufacturer | 3 |
| Shanghai Suoguang Visual Products Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 1 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Gcmedica Enterprise Ltd.(Wuxi) | Wuxi | Jiangsu | Contract manufacturer | 55 |
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Lakong Medical Devices Co., Ltd. | Dongguan | Guangdong | Remanufacturer | 39 |
| Jiangsu Guangda Medical Material Group Co., Ltd. | Haian | Jiangsu | Contract manufacturer | 32 |
| Guilin Yikeshi Medical Device Co Ltd | Guilin | Guangxi | Manufacturer | 28 |
Showing 12 of 22. All 22 manufacturers in China registered for Camera, Surgical And Accessories
Record
| Listed by | NDS Surgical Imaging, LLC., United States |
|---|---|
| FDA product code | KQM |
| Device type | Camera, Surgical And Accessories |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4160 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-08-05 |
| Record revised | 2024-05-03 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2022-08-05 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 90X0597 | In distribution | |
| 90X0656 | In distribution | |
| 90X0562 | In distribution | |
| 90X0682 | In distribution | |
| 90R0077 | In distribution | |
| 90×0566 | In distribution | |
| 90X0471 | In distribution | |
| 90X0717 | In distribution | |
| 90R0111 | In distribution | |
| 90X0568 | In distribution | |
| 90R0117 | In distribution | |
| 90T2093 | In distribution | |
| 90×0576 | In distribution | |
| 90X0670 | In distribution | |
| 90X0706 | In distribution | |
| 90R0054 | In distribution | |
| 90X589 | In distribution | |
| 90X0674 | In distribution | |
| 90R0122 | In distribution | |
| 90X0614 | In distribution | |
| 90X0616 | In distribution | |
| 90X0550 | In distribution | |
| 90X0476 | In distribution | |
| 90X0685 | In distribution | |
| 90X0599 | In distribution | |
| 90R0066 | In distribution | |
| 90R0125 | In distribution | |
| 90X0697 | In distribution | |
| 90X0606 | In distribution | |
| 90X669 | In distribution | |
| 90X0602 | In distribution | |
| 90X0655 | In distribution | |
| 90T2079 | In distribution | |
| 90X0658 | In distribution | |
| 90X0664 | In distribution | |
| 90T2092 | In distribution | |
| 90X0580 | In distribution | |
| 90R0129 | In distribution | |
| 90r0128 | In distribution | |
| 90X0549 | In distribution | |
| 90R0126 | In distribution | |
| 90X0681 | In distribution | |
| 90X0539 | In distribution | |
| 90X0720 | In distribution | |
| 90X0621 | In distribution | |
| 90X0544 | In distribution | |
| 90R0118 | In distribution | |
| 90X0578 | In distribution | |
| 90X0648 | In distribution | |
| 90X0545 | In distribution | |
| 90R0080 | In distribution | |
| 90X0651 | In distribution | |
| 90R0123 | In distribution | |
| 90X0660 | In distribution | |
| 90X0594 | In distribution | |
| 90X0612 | In distribution | |
| 90X0619 | In distribution | |
| 90X0584 | In distribution | |
| 90X0540 | In distribution | |
| 90X0626 | In distribution | |
| 90X0541 | In distribution | |
| 90X0575 | In distribution | |
| 90R0132 | In distribution | |
| 90X0563 | In distribution | |
| 90X0695 | In distribution | |
| 90X0467 | In distribution | |
| 90T2081 | In distribution | |
| 90X0687 | In distribution | |
| 90R0168 | In distribution | |
| 90X0716 | In distribution | |
| 90X0583 | In distribution | |
| 90X0569 | In distribution | |
| 90R0131 | In distribution | |
| 90X0663 | In distribution | |
| 90×0548 | In distribution | |
| 90X0434 | In distribution | |
| 90X534 | In distribution | |
| 90X0680 | In distribution | |
| 90X585 | In distribution | |
| 90X0590 | In distribution | |
| 90X0672 | In distribution | |
| 90X0617 | In distribution | |
| 90R0130 | In distribution | |
| 90X0555 | In distribution | |
| 90X0662 | In distribution | |
| 90R0076 | In distribution | |
| 90R0100 | In distribution | |
| 90X0667 | In distribution | |
| 90X0713 | In distribution | |
| 90X0582 | In distribution | |
| 90X0714 | In distribution | |
| 90X0666 | In distribution | |
| 90X0665 | In distribution | |
| 90X0538 | In distribution | |
| 90X0543 | In distribution | |
| 90X0595 | In distribution | |
| 90X0581 | In distribution | |
| 90X0547 | In distribution | |
| 90X0624 | In distribution | |
| 90X0572 | In distribution | |
| 90T2080 | In distribution | |
| 90X0715 | In distribution | |
| 90X0601 | In distribution | |
| 90R0065 | In distribution | |
| 90X0661 | In distribution | |
| 90R0124 | In distribution | |
| 90X0588 | In distribution | |
| 90X0724 | In distribution | |
| 90X0537 | In distribution | |
| 90X0553 | In distribution | |
| 90R0078 | In distribution | |
| 90T2094 | In distribution | |
| 90X0686 | In distribution | |
| 90R0127 | In distribution | |
| 90R0050 | Withdrawn | |
| 90R0069 | Withdrawn | |
| 90X0719 | Withdrawn | |
| 90R0062 | Withdrawn | |
| 90X06659 | Withdrawn | |
| 90R0052 | Withdrawn | |
| 90R0067 | Withdrawn | |
| 90r0063 | Withdrawn | |
| 90R0071 | Withdrawn | |
| 90X0721 | Withdrawn | |
| 90X0718 | Withdrawn | |
| 90R0053 | Withdrawn | |
| 90R0072 | Withdrawn | |
| 90R0064 | Withdrawn | |
| 90R0068 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Accu-Beam | Transamerican Technologies International | 114 |
| Barco | Barco, Inc | 89 |
| Conmed | ConMed Corporation | 59 |
| EndoVue | NDS Surgical Imaging, LLC. | 50 |
| Sony | Sony Corporation | 42 |
| CuratOR | Eizo Corporation | 38 |
| FSN | Foreseeson Custom Displays, Inc. | 25 |
| ILO | ILO Electronic Gmbh | 25 |
| Camera, Surgical And Accessories | Pentax of America, Inc. | 24 |
| Beacon | Shenzhen Beacon Display Technology Co., Ltd. | 24 |
| Tidishield | Tidi Products, LLC | 22 |
| NDS | Pentax of America, Inc. | 19 |
Showing 12 of 190. All products under Camera, Surgical And Accessories
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.