FLUOROspeed
3 catalogue numbers from 566-23000-03, listed by Shimadzu Corp., United States, under System, X-Ray, Fluoroscopic, Image-Intensified. 9 manufacturers in China are registered for this product code.
9manufacturers in China registered for this device type
3catalogue numbers in this listing
9510(k) clearances naming this product code
Who Else Makes It
Concentrated in Beijing (2), Guangdong (2), Shanghai (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
| GE Hangwei Medical Systems Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| GE Healthcare (China) Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| Ming FAI Enterprise International Co., Ltd. | Kowloon | Hong Kong | Exporter | 18 |
| Ming FAI Industrial (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 17 |
| Shanghai United Imaging Healthcare Co., Ltd. | Shanghai | Shanghai | Manufacturer | 12 |
| Siemens Shanghai, Medical Equipment Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Siemens Shenzhen Magnetic Resonance Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Careray Digital Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 2 |
Record
| Listed by | Shimadzu Corp., United States |
|---|---|
| FDA product code | JAA |
| Device type | System, X-Ray, Fluoroscopic, Image-Intensified |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1650 |
| 510(k) | K191877 |
| Record published | 2021-08-20 |
| Record revised | 2025-05-28 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 566-23000-03 | In distribution | |
| 566-23000-02 | In distribution | |
| 566-23000-01 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Preferred Medical Products, LLC | Preferred Medical Products, LLC | 324 |
| Unbranded | Advance Medical Designs, Inc. | 301 |
| N23 CCD System | Nical SPA | 57 |
| N33 CCD System | Nical SPA | 36 |
| Trinias | Shimadzu Corp. | 31 |
| Custom Cover | Advance Medical Designs, Inc. | 15 |
| Pulse | Nuvasive, Inc. | 15 |
| Sonialvision G4 | Shimadzu Corp. | 13 |
| LessRay | Nuvasive, Inc. | 13 |
| Micro Kover | Advance Medical Designs, Inc. | 11 |
| Stephanix | Stephanix | 10 |
| Snap Kover | Advance Medical Designs, Inc. | 9 |
Showing 12 of 169. All products under System, X-Ray, Fluoroscopic, Image-Intensified
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K191877 | 2019-08-05 |
| K190373 | 2019-03-15 |
| K142341 | 2015-03-06 |
| K131075 | 2014-03-28 |
| K040870 | 2004-05-17 |
| K012424 | 2001-10-18 |
| K933472 | 1994-02-07 |
| K933473 | 1993-11-24 |
| K895394 | 1989-11-13 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Shimadzu Corporation Medical Systems Division | 510(k) number | 2024-09-06 | Class II | Software change control | X-ray R/F system software with certain versions of the control board may occasionally fail to display images when switching from Fluoroscopy mode to Radiography mode, which may lead to the possibility of delay or cancellation of the examina | 30 |
| Shimadzu Medical Systems | 510(k) number | 2022-01-10 | Class II | Software design | It was found that the irradiated x-ray may exceed the xray radiation dose rate specified in CFR 1020.32 in some specific case of fluoroscopic mode due to inadequate adjusting criteria in installation. | 25 systems |
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.