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)

FUJINON ULTRASONIC PROCESSOR

K-Number: K111243 · 2011-05-16

ApplicantFujinon, Inc.
Decision Date2011-05-16
Product CodeFDS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FUJINON ULTRASONIC PROCESSOR is the device name listed in this FDA 510(k) record. The listed applicant is Fujinon, Inc.. It received FDA 510(k) clearance on 2011-05-16 under 510(k) number K111243. The device is classified under product code FDS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FUJINON ULTRASONIC PROCESSOR?

FUJINON ULTRASONIC PROCESSOR is a medical device that received FDA 510(k) clearance on 2011-05-16. The listed applicant is Fujinon, Inc.. The 510(k) number is K111243.

When did FUJINON ULTRASONIC PROCESSOR receive FDA 510(k) clearance?

FUJINON ULTRASONIC PROCESSOR received FDA 510(k) clearance on 2011-05-16, under 510(k) number K111243.

Who is the listed applicant for FUJINON ULTRASONIC PROCESSOR?

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

What is the FDA product code for FUJINON ULTRASONIC PROCESSOR?

The FDA product code for FUJINON ULTRASONIC PROCESSOR is FDS.

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 Fujinon, 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.

K120446FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EG-530UR2 AND EG-530UT2K112391FUJINON COLONOSCOPESK102466FUJINON EPX-4440HD DIGITAL VIDEO PROCESSORK091773FUJINON STERILE OVERTUBESK090116FUJINON COLONOSCOPE FOR DOUBLE BALLOON ENTERSCOPY SYSTEM MODEL, EC-450B15K063316FUJINON MODEL EG-530N TRANS NASAL INSERTION

View all 30 devices →

Related Devices (Code: FDS)

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.

K261400Ambu® aScope™ Gastro; Ambu® aScope™ Gastro LargeAmbu A/SK260856Disposable Distal Attachment D-201-13404Olympus Medical Systems CorporationK260824Gastrointestinal Videoscope Olympus GIF-2T1500Olympus Medical Systems CorporationK253702Intuitive Endoluminal Gastrointestinal System (IG1000)Intuitive Surgical, Inc.K260573EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc.K250550FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display UnitFujifilm Corporation

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.

↑