Bransist Safire
Catalogue number 503-67100-28, listed by Shimadzu Corp., United States, under System, X-Ray, Angiographic. 7 manufacturers in China are registered for this product code.
7manufacturers in China registered for this device type
1catalogue number
6510(k) clearances naming this product code
Who Else Makes It
Concentrated in Shanghai (2), Beijing (2), Guangdong (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| GE Hangwei Medical Systems Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| GE Healthcare (China) Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| Scivita Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 19 |
| Siemens Shanghai, Medical Equipment Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Guangdong Optomedic Technologies, Inc. | Foshan | Guangdong | Manufacturer | 7 |
| Zhuhai Dipu Medical Technology Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 3 |
Record
| Listed by | Shimadzu Corp., United States |
|---|---|
| FDA product code | IZI |
| Device type | System, X-Ray, Angiographic |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1600 |
| 510(k) | K062360 |
| Record published | 2016-09-16 |
| Record revised | 2025-05-28 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 503-67100-28 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sterimed | Sterimed, Inc. | 114 |
| Med-Syringe | Argon Medical Devices, Inc. | 16 |
| Control Syringe | Argon Medical Devices, Inc. | 14 |
| Novadaq and Pinpoint | Novadaq Technologies, Inc. | 12 |
| DeRoyal | Deroyal Industries, Inc. | 12 |
| Namic | Navilyst Medical, Inc. | 9 |
| Namic | Medline Industries, Inc. | 8 |
| iMRX System | Imris Imaging, Inc. | 6 |
| System, X-Ray, Angiographic | B. Braun Medical Inc. | 4 |
| System, X-Ray, Angiographic | Intuitive Surgical, Inc. | 3 |
| Leica FL800 | Leica Microsystems (Schweiz) AG | 3 |
| Infrared 800 with Flow® 800 Option | Carl Zeiss Meditec Inc | 2 |
Showing 12 of 51. All products under System, X-Ray, Angiographic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K072006 | 2007-08-31 |
| K071717 | 2007-07-05 |
| K062360 | 2006-10-05 |
| K032443 | 2004-02-20 |
| K033184 | 2003-12-09 |
| K973342 | 1997-10-08 |
Recalls Naming This Product
3 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 | Closed |
|---|---|---|---|---|---|---|---|
| Shimadzu Medical Systems | 510(k) number | 2021-12-16 | Class II | Process change control | Due to the inadequate adjusting criteria in installation, the system generator on two Digital Angiography Systems, the irradiated x-ray may exceed the x-ray radiation dose rate in fluoroscopic mode. | 18 | |
| Shimadzu Medical Systems | 510(k) number | 2020-11-18 | Class II | Software design | The firm has identified a problem with the control software for the celling arm of the X-Ray System. This software issue could cause the ceiling arm of the device to move after the operator has released the movement lever. This could re | 7 units | |
| Shimadzu Medical Systems Usa Com | 510(k) number | 2019-01-14 | Class II | Software design | Normal operation of the device is to power up the device in the morning, register the first patient, and then perform a fluoroscopy. If, however, the user powers up the device in the morning and makes an error by starting a fluoroscopy whil | 8 units | 2024-06-07 |
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.