Orlando, FL, US · 3 510(k) clearances · 2 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| MOS | Coil, Magnetic Resonance, Specialty | Class II | Radiology | 1 | 2021-12-23 |
| MWI | — | — | — | 1 | 2021-09-30 |
| LLZ | System, Image Processing, Radiological | Class II | Radiology | 1 | 2021-08-02 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2020-09-14 | Class III | Terminated | Z-0126-2021 | MR Coils The MR Coil is intended to be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic im… | — | The labels have been mistakenly printed with an IPX1 rating symbol. IPX ratings relate to protections that products have from water ingress. |
| 2020-02-06 | Class II | Terminated | Z-1440-2020 | Monitor for the Functional Imaging System for Magnetic Resonance Imaging System | — | Insufficient shielding of Philips SensaVue DVI Adapter for computer monitor. |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2021-12-23 | K213766 | dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for 1.5T and 3.0T, ds Small Extremity 16Ch Coils for 1.5T and 3.0T | MOS | Class II | Radiology |
| 2021-09-30 | K212227 | Philips MR Patient Care Portal | MWI | — | — |
| 2021-08-02 | K212175 | DynaCAD | LLZ | Class II | Radiology |