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)

SIASCOPE II

K-Number: K023729 · 2003-02-03

ApplicantAstron Clinica Limited
Decision Date2003-02-03
Product CodePSN
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SIASCOPE II is the device name listed in this FDA 510(k) record. The listed applicant is Astron Clinica Limited. It received FDA 510(k) clearance on 2003-02-03 under 510(k) number K023729. The device is classified under product code PSN. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIASCOPE II?

SIASCOPE II is a medical device that received FDA 510(k) clearance on 2003-02-03. The listed applicant is Astron Clinica Limited. The 510(k) number is K023729.

When did SIASCOPE II receive FDA 510(k) clearance?

SIASCOPE II received FDA 510(k) clearance on 2003-02-03, under 510(k) number K023729.

Who is the listed applicant for SIASCOPE II?

The FDA 510(k) record lists Astron Clinica Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SIASCOPE II?

The FDA product code for SIASCOPE II is PSN.

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 Astron Clinica Limited 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.

K062736SIASCOPE VK011273SI ASCOPE

Related Devices (Code: PSN)

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.

K230448DeepX DermoSight DermatoscopeDeepx Health, LLCK213957Demetra Dermatoscope BDEM-01Barco N.V.K201408Demetra Analytics ToolkitBarco N.V.K192829Demetra BDEM-01 DermatoscopeBarco N.V.K180162VivaScope SystemCaliber Imaging & Diagnostics, Inc.K080788VIVASCOPE SYSTEM, MODEL 1500, 3000Lucid, Inc.

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.

↑