XRpad Digital X-Ray Detector System
XRpad2 3025 is a lightweight wireless cassette detector with advanced features enabling digital radiography as never seen before. Featuring best-in-class 100 μm pixel size, direct…
XRpad2 3025 is a lightweight wireless cassette detector with advanced features enabling digital radiography as never seen before. Featuring best-in-class 100 μm pixel size, direct deposition CsI scintillator and excellent DQE, XRpad2 3025 enables high resolution imaging with reduced X-ray exposure. Design of the second-generation XRpad is lightweight, robust and ergonomic, permitting easy lifting from table top. Automatic Exposure Detection, on-board corrections, and wireless access point mode make system integration quick and simple. New features of the XRpad2 3025 include fast preview, internal image storage, and magnetic connector for docking. Continuous imaging at up to 10 fps facilitates advanced applications such as tomosynthesis, dual energy subtraction, and image stitching.
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 | Perkinelmer, Inc., United States |
|---|---|
| FDA product code | MQB |
| Device type | Solid State X-Ray Imager (Flat Panel/Digital Imager) |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1680 |
| Record published | 2016-07-29 |
| Record revised | 2019-02-21 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Special storage condition: May cause risk of fire, explosion, or a severe burn hazard; Special storage condition: Keep away from children; Special storage condition: Do not crush or expose to fire or incinerate; Handling environment temperature -10 to 55 °C; Handling environment humidity 35 to 85 % RH |
| Sizes | Width 211.2 to 460 mm; weight 0.4 to 4.1 kg; length 230 to 460 mm; depth 15 to 82 mm; length 3 to 20 m; height 6.3 to 113 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| XRpad LPT Detector Cable 20FT-6M | Length 6 m | In distribution |
| XRpad LBP | Weight 0.4 kg | In distribution |
| XRpad2 4336 HWC-M | Weight 3.2 kg | In distribution |
| XRpad 4336 MED | Weight 3.8 kg | In distribution |
| Trigger Cable, 16.5FT → 5M | Length 5 m | In distribution |
| XRpad LPT Detector Cable 10FT-3M | Length 3 m | In distribution |
| Trigger Cable, 65.5FT → 20M | Length 20 m | In distribution |
| XRpad2 3025 HWC-M | Depth 15.5 mm | In distribution |
| XRpad 4343 F MED | Weight 4.1 kg | In distribution |
| XRpad IPU | Width 311 mm | In distribution |
| XRpad LBC | Weight 1.1 kg | In distribution |
| XRpad2 3025 HWC-M | Weight 1.8 kg | In distribution |
| XRpad2 4336 HWC-M | Depth 15.5 mm | 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 |
| Fuji IP Cassette CC | Fujifilm Corporation | 20 |
| 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 |
Showing 12 of 509. All products under Solid State X-Ray Imager (Flat Panel/Digital Imager)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K161966 | 2016-09-08 |
| K161942 | 2016-09-01 |
| K142698 | 2014-10-23 |
| K140551 | 2014-08-01 |
| K122495 | 2012-11-28 |
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.