ARTIS pheno (VE30A)
by Siemens Medical Solutions USA, Inc.
510(k) K230949
ARTIS pheno (VE30A) is a Class II device made by Siemens Medical Solutions USA, Inc., cleared under FDA 510(k) K230949 on 15 Dec 2023, active as of 22 Oct 2026. 2 FDA recalls are linked to it.
Active
Valid until
No expiry
FDA recalls
2 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK230949 | Date15 Dec 2023 | StatusActive |
Official records
- FDA 510(k) database K230949
Recalls
-
- Ongoing Z-1814-2026
During 3D acquisitions, lighter and darker patient images may be captured, which may result in less accurate 3D reconstruction. The variation of brightness is a result of a constant unregulated medium dose and the angular change of patient diameter caused by rotational acquisition. This may result in unintentional low-dose radiation exposure to a patient.
-
- Ongoing Z-2019-2025
In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorrectly report an application of a high dose.
Timeline
- Cleared FDA 510(k) K230949
- Recall initiated FDA recalls Z-2019-2025
- Recall initiated FDA recalls Z-1814-2026
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- OWB
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1650
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent