Flaatz
The FLAATZ 560 is described as a radiographic image acquisition device and an integrated image capture and routing system under human operator control. The filing indicates it generates…
The FLAATZ 560 is described as a radiographic image acquisition device and an integrated image capture and routing system under human operator control.
The filing indicates it generates radiographic images of human anatomy and is intended to replace film-screen systems in general-purpose diagnostic procedures, excluding fluoroscopic, angiographic and mammographic applications.
Listed Item
The FLAATZ 750E detector is a direct conversion device in the form of a square plate in which the input x-ray photons are absorbed in an x-ray sensitive photoconductor.
Image Acquisition Components
The system description lists a detector panel, case, grid, control box, switch box, interconnecting cables and API. The API captures image data and corrects image defects.
The switch box transfers signals between the control box and X-ray generator and indicates panel status with LED lights.
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 | Drtech Corporation, South Korea |
|---|---|
| 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 | Contract manufacturer, Manufacturer |
| 510(k) | K111583 |
| Record published | 2016-09-02 |
| Record revised | 2026-03-20 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FLAATZ 760 | In distribution | |
| FLAATZ 600 | In distribution | |
| FLAATZ 601 | In distribution | |
| FLAATZ 750E | In distribution | |
| FLAATZ 560 | 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 |
|---|---|
| K242770 | 2025-03-20 |
| K243443 | 2025-03-19 |
| K232082 | 2024-02-13 |
| K232753 | 2023-11-16 |
| K231959 | 2023-08-01 |
| K223124 | 2022-11-18 |
| K193031 | 2019-11-22 |
| K193017 | 2019-11-22 |
| K192400 | 2019-10-03 |
| K171137 | 2017-05-15 |
| K162555 | 2016-12-21 |
| K162552 | 2016-12-02 |
| K151942 | 2015-10-21 |
| K142475 | 2015-01-15 |
| K132842 | 2014-02-21 |
| K111583 | 2011-10-04 |
| K102474 | 2011-03-04 |
| K080064 | 2008-01-23 |
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.