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FDA 510(k)

OPTI

K-Number: K063646 · 2007-03-07

ApplicantCamsight Co., Inc.
Decision Date2007-03-07
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OPTI is the device name listed in this FDA 510(k) record. The listed applicant is Camsight Co., Inc.. It received FDA 510(k) clearance on 2007-03-07 under 510(k) number K063646. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTI?

OPTI is a medical device that received FDA 510(k) clearance on 2007-03-07. The listed applicant is Camsight Co., Inc.. The 510(k) number is K063646.

When did OPTI receive FDA 510(k) clearance?

OPTI received FDA 510(k) clearance on 2007-03-07, under 510(k) number K063646.

Who is the listed applicant for OPTI?

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

What is the FDA product code for OPTI?

The FDA product code for OPTI is EIA.

Related PubMed Literature

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.

PMID: 42714465Artificial Intelligence in Indian Dermatology: An IADVL Academy Position Statement and Policy Framework for Safe, Equitable, and Effective Adoption.Indian dermatology online journal ()PMID: 41543479Ethical and Regulatory Considerations for Artificial Intelligence Adoption in Craniofacial Surgery.The Journal of craniofacial surgery ()PMID: 41429289Clinical Evidence to Support US Food and Drug Administration Review of New Medical Technology in Pulmonary, Sleep, and Critical Care Medicine Between 2014 and 2024: A Scoping Review to Support Adoption in Practice.Chest ()PMID: 41055689Regulatory Adoption of AI, ML, Computational Modeling & Simulation in In-Silico Clinical Trials for Medical Devices: A Systematic Review.Therapeutic innovation & regulatory science ()

Other records listing Camsight Co., 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.

K053221CDMX-HK010915CDMX

Related Devices (Code: EIA)

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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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