# K241572: ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A) (ceiling); ARTIS pheno (VE40A)

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Oct 22, 2024 after 144 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K801623 (1980). 61 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230950: ARTIS icono (VE30A), Siemens Medical Solutions USA, Inc. (2023) Summary page 6.
- K221516: ARTIS icono (Ceiling Configuration), Siemens Medical Solutions USA, Inc. (2022) Summary page 6.
- K230949: ARTIS pheno (VE30A), Siemens Medical Solutions USA, Inc. (2023) Summary page 6.

## Most influential descendants
- K254173: ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno (2026), 0 descendants of its own
- K253752: ARTIS genio floor; ARTIS icono.explore floor (2026), 0 descendants of its own

## Recalls of this device
- May 20, 2026 · Class II · Z-2643-2026: Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.
- May 20, 2026 · Class II · Z-2642-2026: Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.
- May 20, 2026 · Class II · Z-2641-2026: Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.
- Mar 12, 2026 · Class II · 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
- Mar 10, 2026 · Class II · Z-1653-2026: During patient examinations, the system may sporadically display a major increase of the x-ray dose applied to the patient. Despite the reported dose showing significantly higher, the actual applied x
- Mar 9, 2026 · Class II · Z-2206-2026: During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. D
- Mar 9, 2026 · Class II · Z-2205-2026: During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. D
- Aug 12, 2025 · Class II · Z-2529-2025: Limited system movements after startup .
- May 15, 2025 · Class II · Z-2021-2025: 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 appl
- May 15, 2025 · Class II · Z-2022-2025: 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 appl
- May 15, 2025 · Class II · Z-2020-2025: 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 appl

## Indications for use
ARTIS is a family of dedicated angiography systems developed for single plane and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the ARTIS family include cardiac angiography, neuro-angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for i.e. patient extremities. This does not include projection radiography. Additional procedures that can be performed include angiography in the operating room, image guided surgery by X-ray, by image fusion, and by navigation systems. The examination table as an integrated part of the system can be used for X-ray imaging, surgery and interventions. The ARTIS systems can also support the acquisition of position triggered imaging for spatial data synthesis. The ARTIS systems include also the software option DynaCT with following indications for use: DynaCT is an X-ray imaging software option, which allows the reconstruction of two-dimensional images acquired with a standard angiographic C-arm device into a three-dimensional image format. DynaCT is intended for imaging both hard and soft tissues as well as other internal body structures for diagnosis, surgical planning, interventional procedures and treatment follow-up.

Source page: https://510kreport.com/device/K241572
Methodology: https://510kreport.com/methodology