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)

HEIDELBERG RETINA ANGIOGRAPH FA/ICGA (HRA/C)

K-Number: K971671 · 1997-07-29

ApplicantHeidelberg Engineering
Decision Date1997-07-29
Product CodeHLI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

HEIDELBERG RETINA ANGIOGRAPH FA/ICGA (HRA/C) is the device name listed in this FDA 510(k) record. The listed applicant is Heidelberg Engineering. It received FDA 510(k) clearance on 1997-07-29 under 510(k) number K971671. The device is classified under product code HLI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEIDELBERG RETINA ANGIOGRAPH FA/ICGA (HRA/C)?

HEIDELBERG RETINA ANGIOGRAPH FA/ICGA (HRA/C) is a medical device that received FDA 510(k) clearance on 1997-07-29. The listed applicant is Heidelberg Engineering. The 510(k) number is K971671.

When did HEIDELBERG RETINA ANGIOGRAPH FA/ICGA (HRA/C) receive FDA 510(k) clearance?

HEIDELBERG RETINA ANGIOGRAPH FA/ICGA (HRA/C) received FDA 510(k) clearance on 1997-07-29, under 510(k) number K971671.

Who is the listed applicant for HEIDELBERG RETINA ANGIOGRAPH FA/ICGA (HRA/C)?

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

What is the FDA product code for HEIDELBERG RETINA ANGIOGRAPH FA/ICGA (HRA/C)?

The FDA product code for HEIDELBERG RETINA ANGIOGRAPH FA/ICGA (HRA/C) is HLI.

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 Heidelberg Engineering 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.

K101223SPECTRALIS HRA+OCT, SPECTRALIS FA_OCT, SPECTRALIS ICGA+ OCT, SPECTRALIS HRA, SPECTRALIS FAK063191HEIDELBERG RETINA ANGIOGRAPH 2/OPTICAL COHERENCE TOMOGRAPH, MODEL HRA 2/OCTK052935HEIDELBERG ENGINEERING SLITLAMP-OCT (SL-OCT)K042742HEIDELBERG RETINA TOMOGRAPH II / ROSTOCK CORNEA MODULE (HRT II / RCM)K943956RETINA TOMOGRAPH AND FLOWMETERK943955RETINA FLOWMETER

View all 9 devices →

Related Devices (Code: HLI)

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.

K153080RTVue XR OCT Avanti with AngioVue SoftwareOptovue, Inc.K123316HEINE OMEGA 500Heine Optotechnik GmbH & Co. KGK121739IVUE WITH NORMATIVE DATABASEOptovue, Inc.K120057ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS)Bioptigen, Inc.K120238RTVUE XR OCTOptovue, Inc.K111531RHA2020Annidis Health Systems 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.

↑