Infx-8000C, V6.20

510(k) K152697

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

This device is named in the recall

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK152697	Date15 Jan 2016Cleared	StatusActive

5 recalls · 3 ongoing · FDA

- Ongoing Z-1175-2021 FDA Class II initiated 5 Feb 2021
The x-ray irradiation field may shift with respect to image receiving surface displayed on the screen at some C-arm angles.
- Ongoing Z-1270-2021 FDA Class II initiated 8 Dec 2020
System table may tilt because the bolts that fasten the vertical column and the table top tilting drive unit may become loose.
- Ongoing Z-2326-2020 FDA Class II initiated 3 Mar 2020
Bolts holding the longitudinal movement of catheterization tables may be loose, which may lead to table surface/top tilting.
- Terminated Z-0532-2021 FDA Class II initiated 8 Oct 2020
There is a potential that the cable of the Flat panel detector may break during a procedure which may cause the x-ray device to stop before the examination is completed. This could result in a delay with procedure and/or potential damage to the patients blood vessels due to removal without visibility.
- Terminated Z-0843-2018 FDA Class II initiated 29 Dec 2017
During an examination a device error occurred and the ceiling drive operation was disabled. It was found that the fastening bolts of the driving portion of the ceiling drive loosened cause the error.

1 jurisdiction

United States — FDA 510(k) Active

510(k)