AXIOM ARISTOS FX (MULTI PURPOSE RADIOGRAPHY SYSTEM)— 510(k) K013826

Clearance details

Applicant

Siemens Medical Systems, Inc.

Product code

Code KPR

Device class

Class 2

Regulation

21 CFR 892.1680

Advisory panel

Radiology

Date received

2001-11-19

Decision date

2002-02-01

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Iselin, NJ, US

• K260227 — EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50H2026-09-08
• K260488 — MULTIX Impact; MULTIX Impact C2026-08-31
• K260481 — GC85A2026-08-27
• K260482 — DRE Duo2026-06-15
• K253446 — AeroDR TX c022026-04-10

• K133646 — ADMIRE2014-06-20
• K130901 — SOMATOM DEFINITION AS OPEN2014-01-02
• K123540 — SYNGO CT PULMO 3D2013-08-29
• K123541 — SYNGO.CT NEURO PERFUSION2013-04-02
• K122909 — SYNGO SINGLE SOURCE DUAL ENGERY2012-12-27

Other

6

Total

6

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1764-2020 — System AXIOM Aristos FX - Product Usage: A dedicated x-ray system with a flat panel detector which allows the acquisition of x-ray exposures without the use of conventional film/screen systems. The MPRS allows radiographic exposures of the whole body including skull, spinal column, chest, abdomen, extremities, and excluding mammography. Radiographic exposures may be taken with the patient in sitting, standing, or supine positions.Class II·Terminated·Siemens Medical Solutions USA, Inc·20200406
• Z-1583-2015 — AXIOM ARISTOS FX; Multipurpose Radiography System (MPRS) is a dedicated x-ray system with a flat panel detector which allows the acquisition of x-ray exposures without the use of conventional film/screen systems. The MPRS allows radiographic exposures of the whole body including skull, spinal column, chest, abdomen, extremities, and excluding mammography. Radiographic exposures may be taken with the patient in the sitting, standing, or supine positions. The intended use and indications for use of this modified device as described in its labeling have not changed from its predicate device.Class II·Terminated·Siemens Medical Solutions USA, Inc·20150414

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K013826.