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FDA 510(k)

PANORAMIC 200A

K-Number: K042001 · 2004-10-07

ApplicantOptos Plc.
Decision Date2004-10-07
Product CodeHLI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

PANORAMIC 200A is the device name listed in this FDA 510(k) record. The listed applicant is Optos Plc.. It received FDA 510(k) clearance on 2004-10-07 under 510(k) number K042001. 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 PANORAMIC 200A?

PANORAMIC 200A is a medical device that received FDA 510(k) clearance on 2004-10-07. The listed applicant is Optos Plc.. The 510(k) number is K042001.

When did PANORAMIC 200A receive FDA 510(k) clearance?

PANORAMIC 200A received FDA 510(k) clearance on 2004-10-07, under 510(k) number K042001.

Who is the listed applicant for PANORAMIC 200A?

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

What is the FDA product code for PANORAMIC 200A?

The FDA product code for PANORAMIC 200A is HLI.

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Other records listing Optos Plc. 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.

K233602P200TE (A10700)K231673P200TE (A10700)K190732P200TxEK173707P200TEK162039OptosAdvance 4.0 SoftwareK121043OPTOS OCT/SLO MICROPERIMETER

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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.

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