Fuji IP Cassette CC
The FUJI IP CASSETTE (hereinafter referred to as the cassette) is a cassette used on the Image Reader. The cassette is used with an Imaging Plate (hereinafter referred to as the IP) loaded…
The FUJI IP CASSETTE (hereinafter referred to as the cassette) is a cassette used on the Image Reader. The cassette is used with an Imaging Plate (hereinafter referred to as the IP) loaded in it.R36
Who Else Makes It
Concentrated in Shanghai (5), Jiangsu (4), Beijing (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shantou Institute OF Ultrasonic Instruments Co., Ltd. | Shantou | Guangdong | Contract manufacturer | 8 |
| iRay Imaging Technology (Haining) Limited | Haining | Zhejiang | Contract manufacturer | 6 |
| iRay Imaging Technology Taicang Limited | Taicang | Jiangsu | Contract manufacturer | 3 |
| GE Hangwei Medical Systems Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| GE Healthcare (China) Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| Shanghai United Imaging Healthcare Co., Ltd. | Shanghai | Shanghai | Manufacturer | 12 |
| Siemens Shanghai, Medical Equipment Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Carestream Health, Inc., Global R&D Center | Shanghai | Shanghai | Specification developer | 8 |
| Philips Healthcare (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 5 |
| iRay Group | Shanghai | Shanghai | Specification developer | 4 |
| Fujifilm Imaging System (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 3 |
| Careray Digital Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 2 |
Showing 12 of 13. All 13 manufacturers in China registered for Solid State X-Ray Imager (Flat Panel/Digital Imager)
Record
| Listed by | Fujifilm Corporation, Japan |
|---|---|
| FDA product code | MQB |
| Device type | Solid State X-Ray Imager (Flat Panel/Digital Imager) |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1680 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K042023 |
| Record published | 2016-09-16 |
| Record revised | 2024-07-25 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Storage environment temperature 10 to 45 °C; Storage environment humidity 10 to 90 % RH |
| Packaging | Box of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CC BWPB 18X24cm | 18X24 CM | In distribution |
| CC BW 15X30 | 15X30 CM | In distribution |
| CC BWPB 15X30 | 15X30 CM | In distribution |
| CC BW 18X24cm | 18X24 CM | In distribution |
| CC BWPB 35.4X43.0cm(14X17) | 35.4X43.0 CM | In distribution |
| CC BW 35.4X35.4cm(14X14) | 35.4X35.4 CM | In distribution |
| CC BWPB 20.1X25.2cm(8X10) | 20.1X25.2 CM | In distribution |
| CC BW 20.1X25.2cm(8X10) | 20.1X25.2 CM | In distribution |
| CC BWPB 25.2X30.3cm(10X12) | 25.2X30.3 CM | In distribution |
| CC BWPB 20.1X25.2cm(8X10) | 20.1X25.2 CM | In distribution |
| CC BWPB 18X24cm | 18X24 CM | In distribution |
| CC BW 35.4X43.0cm(14X17) | 35.4X43.0 CM | In distribution |
| CC BW 24X30cm | 24X30 CM | In distribution |
| CC BWPB 35.4X35.4cm(14X14) | 35.4X35.4 CM | In distribution |
| CC BWPB 35.4X35.4cm(14X14) | 35.4X35.4 CM | In distribution |
| CC BWPB 24X30cm | 24X30 CM | In distribution |
| CC BWPB 24X30cm | 24X30 CM | In distribution |
| CC BWPB 35.4X43.0cm(14X17) | 35.4X43.0 CM | In distribution |
| CC BWPB 25.2X30.3cm(10X12) | 25.2X30.3 CM | In distribution |
| CC BW 25.2X30.3cm(10X12) | 25.2X30.3 CM | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sedecal | Sedecal., Sa. | 70 |
| Schick33 | Sirona Dental, Inc. | 44 |
| Drgem | Drgem Corporation | 41 |
| Schick | Dentsply LLC | 35 |
| Wireless Digital Flat Panel Detector | iRay Group | 27 |
| Canon Inc. | Canon Inc. | 20 |
| Fona Stellaris | Sirona Dental, Inc. | 20 |
| Exprimer | Drtech Corporation | 18 |
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | Samsung Electronics Co., Ltd. | 17 |
| X-ray Flat Panel Detector | Careray Digital Medical Technology Co., Ltd. | 16 |
| Regius Cassette | Konica Minolta, Inc. | 16 |
| Aadco | Aadco Medical, Inc. | 15 |
Showing 12 of 509. All products under Solid State X-Ray Imager (Flat Panel/Digital Imager)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K200668 | 2020-04-10 |
| K192932 | 2019-11-12 |
| K192440 | 2019-11-01 |
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.