Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

AXIOM ARISTOS FX (MULTI PURPOSE RADIOGRAPHY SYSTEM)

K-Number: K013826 · 2002-02-01

ApplicantSiemens Medical Systems, Inc.
Decision Date2002-02-01
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AXIOM ARISTOS FX (MULTI PURPOSE RADIOGRAPHY SYSTEM) is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Systems, Inc.. It received FDA 510(k) clearance on 2002-02-01 under 510(k) number K013826. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AXIOM ARISTOS FX (MULTI PURPOSE RADIOGRAPHY SYSTEM)?

AXIOM ARISTOS FX (MULTI PURPOSE RADIOGRAPHY SYSTEM) is a medical device that received FDA 510(k) clearance on 2002-02-01. The listed applicant is Siemens Medical Systems, Inc.. The 510(k) number is K013826.

When did AXIOM ARISTOS FX (MULTI PURPOSE RADIOGRAPHY SYSTEM) receive FDA 510(k) clearance?

AXIOM ARISTOS FX (MULTI PURPOSE RADIOGRAPHY SYSTEM) received FDA 510(k) clearance on 2002-02-01, under 510(k) number K013826.

Who is the listed applicant for AXIOM ARISTOS FX (MULTI PURPOSE RADIOGRAPHY SYSTEM)?

The FDA 510(k) record lists Siemens Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AXIOM ARISTOS FX (MULTI PURPOSE RADIOGRAPHY SYSTEM)?

The FDA product code for AXIOM ARISTOS FX (MULTI PURPOSE RADIOGRAPHY SYSTEM) is KPR.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Siemens Medical Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K123540SYNGO CT PULMO 3DK123541SYNGO.CT NEURO PERFUSIONK122909SYNGO SINGLE SOURCE DUAL ENGERYK122471SOMATOM DEFINITIONK120579SOMATOM DEFINITION EDGEK121072SOMATOM DEFINITION FLASH

View all 23 devices →

Related Devices (Code: KPR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260227EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50HDRTECH CorporationK260488MULTIX Impact; MULTIX Impact CSiemens Medical Solutions USA, Inc.K260481GC85ASamsung Electronics Co., Ltd.K260482DRE DuoJpi Healthcare Co, Ltd.K253446AeroDR TX c02Dk Medical Systems Co., Ltd.K250954DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detectorCarestream Health

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑