Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT with Multicolor

K-Number: K172649 · 2017-11-01

ApplicantHeidelberg Engineering GmbH
Decision Date2017-11-01
Product CodeOBO
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT with Multicolor is a medical device manufactured by Heidelberg Engineering GmbH. It received FDA 510(k) clearance on 2017-11-01 under approval number K172649. The device is classified under product code OBO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT with Multicolor?

Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT with Multicolor is a medical device that received FDA 510(k) clearance on 2017-11-01. It is manufactured by Heidelberg Engineering GmbH. The 510(k) number is K172649.

When was Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT with Multicolor approved by the FDA?

Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT with Multicolor received FDA 510(k) clearance on 2017-11-01, under approval number K172649.

What company makes Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT with Multicolor?

Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT with Multicolor is manufactured by Heidelberg Engineering GmbH.

What is the FDA product code for Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT with Multicolor?

The FDA product code for Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT with Multicolor is OBO.

Other Devices by Heidelberg Engineering GmbH

K152205Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT ith Multicolor K182569Spectralis HRA+OCT and variants with High Magnification Module K181594Spectralis HRA+OCT and variants with OCT Angiography Module K173648Spectralis HRA + OCT and variants K192391Spectralis HRA+OCT and Variants K201252Spectralis HRA+OCT and variants

View all 15 devices →

Related Devices (Code: OBO)

K162783EnFocus 2300, EnFocus 4400Bioptigen, Inc. K161194PLEX Elite 9000 SS-OCTCarl Zeiss Meditec, Inc. K1615093D OCT-1 MaestroTopcon Corporation K152205Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT ith MulticolorHeidelberg Engineering GmbH K163195PRIMUSCarl Zeiss Suzhou Co., Ltd. K163475iVueOptovue, 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.

↑