Known Identifiers & Locations
FEI Numbers
2020563
Owner Operator Numbers
N/A
Locations Covered
N/A
Registered Establishments (0)
No device registration and listing records found for this entity.
510(k) Premarket Notifications (0)
No 510(k) notifications found for this entity.
FDA Recall History (1)
| Recall # |
Product Description |
Initiation Date |
Status |
Action |
| Z-0037-2026 |
This device is a digital radiography/fluoroscopy system used in a diagnostic
and interventional angiography configuration. The system is indicated for use in diagnostic and
angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.
Reason: It has been found that when SPOT Fluoro is first turned on, the default ROI is selected and the collimator blades move to the boundary of the ROI, and the static image is overlayed around the ROI,
covering the collimated area. If the customer changes the ROI, the collimator blades and static images
are adjusted accordingly. However, when the acquisition program is changed, the collimator returns to
the default ROI position which may be larger than the specified one, leaving the X-ray area partially
covered by the static image. This is a software problem with the SPOT Fluoro program and will not
occur if the function is not used.
|
2025-09-02 |
Open, Classified
|
View Details
|
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