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)

LINEAR ARRAY SCANNER

K-Number: K800805 · 1980-07-21

ApplicantPhilips Medical Systems (Cleveland), Inc.
Decision Date1980-07-21
Product CodeDXK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LINEAR ARRAY SCANNER is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems (Cleveland), Inc.. It received FDA 510(k) clearance on 1980-07-21 under 510(k) number K800805. The device is classified under product code DXK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LINEAR ARRAY SCANNER?

LINEAR ARRAY SCANNER is a medical device that received FDA 510(k) clearance on 1980-07-21. The listed applicant is Philips Medical Systems (Cleveland), Inc.. The 510(k) number is K800805.

When did LINEAR ARRAY SCANNER receive FDA 510(k) clearance?

LINEAR ARRAY SCANNER received FDA 510(k) clearance on 1980-07-21, under 510(k) number K800805.

Who is the listed applicant for LINEAR ARRAY SCANNER?

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

What is the FDA product code for LINEAR ARRAY SCANNER?

The FDA product code for LINEAR ARRAY SCANNER is DXK.

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 Philips Medical Systems (Cleveland), 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.

K171850Philips CT Big BoreK172406Ingenuity TFK162838Philips iCT CT SystemK163711IQon Spectral CTK170086Pinnacle Radiation Therapy Planning SystemK160743Philips Ingenuity CT

View all 190 devices →

Related Devices (Code: DXK)

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.

K181042Ultra ICE Plus – PI 9 MHz Peripheral Imaging CatheterBoston Scientific CorporationK160173Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)Boston Scientific CorporationK031148IN-VISION IMAGING SYSTEMJomed, Inc.K9348879750 ATHENA ETHERNET OPTIONS & W Medico Teknik A/SK913209ACCESSORY TO GENESIS III (GCFM)Biosound, Inc.K911384CATHSCANNER(R) VISIONS(TM) 3.5F 54700/5.0F 54600Endosonics Corp.

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.

↑