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FDA 510(k)

Optimized Positioning System (OPS) Insight

K-Number: K192656 · 2020-05-01

ApplicantCorin USA
Decision Date2020-05-01
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Optimized Positioning System (OPS) Insight is the device name listed in this FDA 510(k) record. The listed applicant is Corin USA. It received FDA 510(k) clearance on 2020-05-01 under 510(k) number K192656. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Optimized Positioning System (OPS) Insight?

Optimized Positioning System (OPS) Insight is a medical device that received FDA 510(k) clearance on 2020-05-01. The listed applicant is Corin USA. The 510(k) number is K192656.

When did Optimized Positioning System (OPS) Insight receive FDA 510(k) clearance?

Optimized Positioning System (OPS) Insight received FDA 510(k) clearance on 2020-05-01, under 510(k) number K192656.

Who is the listed applicant for Optimized Positioning System (OPS) Insight?

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

What is the FDA product code for Optimized Positioning System (OPS) Insight?

The FDA product code for Optimized Positioning System (OPS) Insight is LLZ.

Other records listing Corin USA 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.

K203751OMNIVision systemK202805Optimized Positioning System (OPS) InsightK193545Corin Optimized Positioning System (OPS) FemoralPMA P050016Prosthesis, hip, semi-constrained, metal/metal, resurfacingK193042Optimized Positioning System (OPS) ReViewK190143LARS AC Band Device

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Related Devices (Code: LLZ)

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.

K262449AdvaViewADVAHEALTH SOLUTIONS, LLCK261916NeuroQuant PETCortechs Labs, Inc.K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K260588Cleerly LABSCleerly, Inc.K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific CorporationK262143ImageGrid StreamVueCandelis, 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.

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