Trinias
54 catalogue numbers from 503-79863-28, listed by Shimadzu Corp., United States, under Interventional Fluoroscopic X-Ray System. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
54catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Beijing (2), Shanghai (2), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 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 |
| Siemens Shenzhen Magnetic Resonance Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
Record
| Listed by | Shimadzu Corp., United States |
|---|---|
| FDA product code | OWB |
| Device type | Interventional Fluoroscopic X-Ray System |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1650 |
| 510(k) | K203535 |
| 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 |
|---|---|---|
| 503-79863-28 | In distribution | |
| 563-79863-88 | In distribution | |
| 563-79863-89 | In distribution | |
| 563-79863-79 | In distribution | |
| 563-79861-27 | In distribution | |
| 563-79861-29 | In distribution | |
| 503-79861-47 | In distribution | |
| 503-79416-04 | In distribution | |
| 563-79864-07 | In distribution | |
| 503-79861-08 | In distribution | |
| 563-79864-87 | In distribution | |
| 503-79863-07 | In distribution | |
| 503-79863-48 | In distribution | |
| 503-79864-47 | In distribution | |
| 563-79861-07 | In distribution | |
| 563-79861-28 | In distribution | |
| 503-79864-27 | In distribution | |
| 563-79863-07 | In distribution | |
| 503-79416-03 | In distribution | |
| 563-79863-87 | In distribution | |
| 503-79832-44 | In distribution | |
| 503-79861-07 | In distribution | |
| 563-79863-77 | In distribution | |
| 503-79863-08 | In distribution | |
| 503-79863-27 | In distribution | |
| 563-79863-28 | In distribution | |
| 563-79863-48 | In distribution | |
| 563-79864-97 | In distribution | |
| 503-79869-45 | In distribution | |
| 503-79861-48 | In distribution | |
| 503-79863-47 | In distribution | |
| 563-79861-48 | In distribution | |
| 563-79863-27 | In distribution | |
| 563-79861-08 | In distribution | |
| 563-79863-78 | In distribution | |
| 563-79863-08 | In distribution | |
| 563-79864-27 | In distribution | |
| 503-79869-47 | In distribution | |
| 503-79861-27 | In distribution | |
| 563-79863-09 | In distribution | |
| 563-79863-97 | In distribution | |
| 563-79863-98 | In distribution | |
| 503-79864-07 | In distribution | |
| 563-79863-49 | In distribution | |
| 563-79863-29 | In distribution | |
| 503-79869-44 | In distribution | |
| 563-79863-47 | In distribution | |
| 563-79863-99 | In distribution | |
| 563-79861-09 | In distribution | |
| 563-79864-77 | In distribution | |
| 503-79861-28 | In distribution | |
| 563-79861-47 | In distribution | |
| 563-79864-47 | In distribution | |
| 563-79861-49 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| TrackX | Trackx Technology Inc. | 86 |
| Allura Xper FD | Philips Medical Systems Nederland B.V. | 21 |
| Azurion | Philips Medical Systems Nederland B.V. | 19 |
| LessRay | Nuvasive, Inc. | 16 |
| Intelli-C Accessory | Nrt – Nordisk Røntgen Teknik A/S | 13 |
| Pulse | Nuvasive, Inc. | 12 |
| O-ARM® | Medtronic Navigation, Inc. | 11 |
| Genoray | Genoray Co., Ltd. | 10 |
| Fujifilm Healthcare Americas Corporation | A.T.S. Applicazione Tecnologie Speciali SRL | 7 |
| Fujifilm Medical Systems U.S.A. Inc. | A.T.S. Applicazione Tecnologie Speciali SRL | 6 |
| Stephanix | A.T.S. Applicazione Tecnologie Speciali SRL | 6 |
| Amrad Medical | A.T.S. Applicazione Tecnologie Speciali SRL | 6 |
Showing 12 of 122. All products under Interventional Fluoroscopic X-Ray System
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252099 | 2026-03-24 |
| K123508 | 2014-02-26 |
Recalls Naming This Product
8 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 | 2026-04-20 | Class II | Component design/selection | Electromagnetic contactors within high voltage generator may weld together, resulting in current being supplied to power supply even if power is off. | 3487 units | |
| Shimadzu Corporation Medical Systems Division | 510(k) number | 2024-09-06 | Class II | Software Design Change | If digital angiography system is used with a specific catheterization table and the operator directs simultaneous movement of the table and the C-arm using direct memory, then direct memory button is released, the table may continue to move | 13 | |
| Shimadzu Corporation Medical Systems Division | 510(k) number | 2024-01-29 | Class II | Process change control | Due to capacitor manufacturing issue, their is a potential that Flat Panel Device may have abnormal display or no function. | 1 | |
| 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. | 28 systems | |
| 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 | 23 units | |
| Shimadzu Medical Systems | 510(k) number | 2019-11-04 | Class II | Device Design | The DAP meters were found to be outside of tolerance. | 3 devices | |
| Shimadzu Medical Systems Usa Com | 510(k) number | 2019-01-14 | Class II | Software design | Two issues: Event 1: 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 start | 13 units | 2021-04-30 |
| Shimadzu Medical Systems Usa Com | 510(k) number | 2018-06-15 | Class II | Software design | Due to a software issue the C-arm may unexpectedly moved when being moved to the park position and during specific operations. There is a possibility the C-arm will come into contact with a patient or healthcare personnel. | 1 | 2021-04-28 |
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.