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)

VANGUARD XR-350 CINEANGIOGRAM PROJECTOR

K-Number: K953563 · 1995-10-05

ApplicantJamieson Film Co.
Decision Date1995-10-05
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VANGUARD XR-350 CINEANGIOGRAM PROJECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Jamieson Film Co.. It received FDA 510(k) clearance on 1995-10-05 under 510(k) number K953563. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VANGUARD XR-350 CINEANGIOGRAM PROJECTOR?

VANGUARD XR-350 CINEANGIOGRAM PROJECTOR is a medical device that received FDA 510(k) clearance on 1995-10-05. The listed applicant is Jamieson Film Co.. The 510(k) number is K953563.

When did VANGUARD XR-350 CINEANGIOGRAM PROJECTOR receive FDA 510(k) clearance?

VANGUARD XR-350 CINEANGIOGRAM PROJECTOR received FDA 510(k) clearance on 1995-10-05, under 510(k) number K953563.

Who is the listed applicant for VANGUARD XR-350 CINEANGIOGRAM PROJECTOR?

The FDA 510(k) record lists Jamieson Film Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VANGUARD XR-350 CINEANGIOGRAM PROJECTOR?

The FDA product code for VANGUARD XR-350 CINEANGIOGRAM PROJECTOR is IZI.

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 Jamieson Film Co. 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.

K970738KODAK DIGITAL SCIENCE CARDIAC DIGITAL ACQUISITION UNITK971128CAP-35B III/CINE 275K963334JAMIESON MODEL 2100 CINE FILM PROCESSOR AND KODAK CINEFLURE PROCESSOR MODEL 2100K960043KODAK CARDIOLOGY DIGITAL ARCHIVE & REVIEW SYSTEMK913241JAMIESON JT-CRP CINE FILM PROCESSOR

Related Devices (Code: IZI)

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.

K261037780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemStryker EndoscopyK253181SURGIMAGE SIM 1000H Fluorescence Imaging PlatformSurgimage CorporationK243645IC-Flow™ Imaging System 2.0Diagnostic Green GmbHK243077Affirm 800Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)K231986Modus IRSynaptive Medical, Inc.K234090EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)Surgvision 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.

↑