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 3 ; RetCam Shuttle ; RetCam Portable

K-Number: K182263 · 2018-09-07

ApplicantNatus Medical Incorporated
Decision Date2018-09-07
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

RetCam 3 ; RetCam Shuttle ; RetCam Portable is the device name listed in this FDA 510(k) record. The listed applicant is Natus Medical Incorporated. It received FDA 510(k) clearance on 2018-09-07 under 510(k) number K182263. 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 3 ; RetCam Shuttle ; RetCam Portable?

RetCam 3 ; RetCam Shuttle ; RetCam Portable is a medical device that received FDA 510(k) clearance on 2018-09-07. The listed applicant is Natus Medical Incorporated. The 510(k) number is K182263.

When did RetCam 3 ; RetCam Shuttle ; RetCam Portable receive FDA 510(k) clearance?

RetCam 3 ; RetCam Shuttle ; RetCam Portable received FDA 510(k) clearance on 2018-09-07, under 510(k) number K182263.

Who is the listed applicant for RetCam 3 ; RetCam Shuttle ; RetCam Portable?

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

What is the FDA product code for RetCam 3 ; RetCam Shuttle ; RetCam Portable?

The FDA product code for RetCam 3 ; RetCam Shuttle ; RetCam Portable is HKI.

Other records listing Natus Medical Incorporated 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.

K182178neoBLUE blanket LED Phototherapy SystemK160745neoBLUE compact LED Phototherapy SystemK160305neoBLUE® LED Phototherapy System

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.

↑