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# FDA 510(k) clearances and recalls: Radiology devices, page 2 of 2

Records 51 to 56 of the 56 newest listed for this hub. Source: U.S. FDA openFDA.

[1](/hub/fdapulse/specialty/radiology) 2

| Record | Specialty | Type | Date |
|---|---|---|---|
| Embrace Vision Neonatal MRI System (K261758): 510(k) cleared for Aspect Imaging, Ltd. | Radiology | 510(k) | 2026-09-16 |
| SPINEsim v1.0 (K261861): 510(k) cleared for Mdsim S.A. | Radiology | 510(k) | 2026-09-15 |
| Artificial Intelligence Renal Assessment (AIRA) Version 1 (K261677): 510(k) cleared for Aramis Global AI Consultancies, LLC | Radiology | 510(k) | 2026-09-15 |
| qCT Lung (v1.0) (K261517): 510(k) cleared for Qure.Ai Technologies Pvt. , Ltd. | Radiology | 510(k) | 2026-09-14 |
| MICSI-PET (K261305): 510(k) cleared for Microstructure Imaging, Inc. | Radiology | 510(k) | 2026-09-11 |
| SpaceOAR Flex™ System (K262151): 510(k) cleared for Boston Scientific Corporation | Radiology | 510(k) | 2026-09-11 |

[1](/hub/fdapulse/specialty/radiology) 2

[All FDAPulse record reports](/hub/fdapulse/records)

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