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)

X-RAY SYSTEM XR-MX

K-Number: K004037 · 2001-02-02

ApplicantKarl Storz Endoscopy
Decision Date2001-02-02
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

X-RAY SYSTEM XR-MX is the device name listed in this FDA 510(k) record. The listed applicant is Karl Storz Endoscopy. It received FDA 510(k) clearance on 2001-02-02 under 510(k) number K004037. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the X-RAY SYSTEM XR-MX?

X-RAY SYSTEM XR-MX is a medical device that received FDA 510(k) clearance on 2001-02-02. The listed applicant is Karl Storz Endoscopy. The 510(k) number is K004037.

When did X-RAY SYSTEM XR-MX receive FDA 510(k) clearance?

X-RAY SYSTEM XR-MX received FDA 510(k) clearance on 2001-02-02, under 510(k) number K004037.

Who is the listed applicant for X-RAY SYSTEM XR-MX?

The FDA 510(k) record lists Karl Storz Endoscopy as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for X-RAY SYSTEM XR-MX?

The FDA product code for X-RAY SYSTEM XR-MX is JAA.

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 Karl Storz Endoscopy 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.

K043375FISCH TITANIUM MIDDLE EAR PROSTHESESK030848PERFORATED BIOABSORBABLE INTERFERENCE SCREW MEGAFIXK030009KSEA POWERSHAVER SYSTEM S2K023924AUTOCON II 200 ELECTROSURGICAL GENERATORK023187KSEA SPINOSCOPEK011700MODULITH SLK LITHOTRIPTER

View all 35 devices →

Related Devices (Code: JAA)

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.

K253103Nexus DRF Digital X-ray Imaging SystemVarex Imaging CorporationK251650Insight Enhanced™ DRF (EN-1002-01)Imaging Engineering, LLCK242488Soteria E-ViewOmega Medical Imaging, LLCK242948Adora DRFi (04550010)Nrt X-Ray A/SK233380TRIDENT Mobile Fluoroscopy SystemDornier Medtech AmericaK233945ProxiDiagnost N90 / Precision CRF (706110, 706400)Philips Medical Systems Dmc GmbH

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.

↑