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)

RetCam Envision

K-Number: K203500 · 2021-04-13

ApplicantNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
Decision Date2021-04-13
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

RetCam Envision is the device name listed in this FDA 510(k) record. The listed applicant is Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek). It received FDA 510(k) clearance on 2021-04-13 under 510(k) number K203500. 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 RetCam Envision?

RetCam Envision is a medical device that received FDA 510(k) clearance on 2021-04-13. The listed applicant is Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek). The 510(k) number is K203500.

When did RetCam Envision receive FDA 510(k) clearance?

RetCam Envision received FDA 510(k) clearance on 2021-04-13, under 510(k) number K203500.

Who is the listed applicant for RetCam Envision?

The FDA 510(k) record lists Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RetCam Envision?

The FDA product code for RetCam Envision is HKI.

Other records listing Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) 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.

K242930Natus BrainWatch SystemK233649ALGO Pro Newborn Hearing Screener (ALGO Pro)K200878Natus NeuroWorksK173936Natus Photic StimulatorK180290Natus Brain Monitor AmplifierK180421Natus NeuroWorks

View all 13 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.

↑