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)

TRC-50DX RETINAL CAMERA

K-Number: K123101 · 2013-06-05

ApplicantTopcon Medical Systems, Inc.
Decision Date2013-06-05
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

TRC-50DX RETINAL CAMERA is the device name listed in this FDA 510(k) record. The listed applicant is Topcon Medical Systems, Inc.. It received FDA 510(k) clearance on 2013-06-05 under 510(k) number K123101. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRC-50DX RETINAL CAMERA?

TRC-50DX RETINAL CAMERA is a medical device that received FDA 510(k) clearance on 2013-06-05. The listed applicant is Topcon Medical Systems, Inc.. The 510(k) number is K123101.

When did TRC-50DX RETINAL CAMERA receive FDA 510(k) clearance?

TRC-50DX RETINAL CAMERA received FDA 510(k) clearance on 2013-06-05, under 510(k) number K123101.

Who is the listed applicant for TRC-50DX RETINAL CAMERA?

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

What is the FDA product code for TRC-50DX RETINAL CAMERA?

The FDA product code for TRC-50DX RETINAL CAMERA is HKI.

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 Topcon Medical Systems, 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.

K182376HarmonyK132438IMAGENET 5 PC SOFTWARE SYSTEMK132667SYNERGY ODMK123460TRC-NW300 NON-MYDRIATIC RETINAL CAMERAK110489SLIT LAMP SL-2GK093313SYNERGY

View all 10 devices →

Related Devices (Code: HKI)

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.

K253176TearViewBeyond 700 Pty, Ltd.K251353Eyer 2Phelcom TechnologiesK252120Fundus On Phone Non Mydriatic (FOP NM-10)Remidio Innovative Solutions Private LimitedK250770Optina-4C (MHRC-C1N)Optina Diagnostics, Inc.K2436003nethra neo HD FA; 3nethra neo HDForus Health Pvt.LtdK250683Resolve Fundus CameraOptain Health, 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.

↑