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FDA 510(k)

OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System

K-Number: K203578 · 2021-02-25

ApplicantPerimeter Medical Imaging Ai, Inc.
Decision Date2021-02-25
Product CodeNQQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System is a medical device manufactured by Perimeter Medical Imaging Ai, Inc.. It received FDA 510(k) clearance on 2021-02-25 under approval number K203578. The device is classified under product code NQQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System?

OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System is a medical device that received FDA 510(k) clearance on 2021-02-25. It is manufactured by Perimeter Medical Imaging Ai, Inc.. The 510(k) number is K203578.

When was OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System approved by the FDA?

OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System received FDA 510(k) clearance on 2021-02-25, under approval number K203578.

What company makes OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System?

OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System is manufactured by Perimeter Medical Imaging Ai, Inc..

What is the FDA product code for OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System?

The FDA product code for OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System is NQQ.

Related Clinical Trials

NCT01143454 Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System RECRUITING NCT06797765 Optical Coherence Tomography Angiography in Neurological Disease COMPLETED NCT02710916 SD-OCT Multimodal Analysis in GLaucoma COMPLETED NCT05493904 PREcise Percutaneous Coronary Intervention for Stent OptimizatION in Treatment of COMPLEX Lesion (PRECISION-COMPLEX) ACTIVE_NOT_RECRUITING NCT07221565 Electromagnetic Immunotherapy Mapping and Cytokine Forecasting Study (QSIT) ENROLLING_BY_INVITATION NCT05225935 Computed Tomography-Guided Catheter Ablation for Ventricular Tachycardia COMPLETED

Other Devices by Perimeter Medical Imaging Ai, Inc.

PMA P250008OCT imaging system with AI/ML software for adjunctive detection of breast cancer

Related Devices (Code: NQQ)

K162466LuminScan (TM) Imaging SystemMicro-Tech (Nanjing) Co., Ltd. K153283VivoSight Dx Topical OCT SystemMichelson Diagnostics, Ltd. K160878OPTIS Metallic Stent Optimization E.4 SWLightlab Imaging, Inc. K160240Perimeter Otis™ 1.0 Optical Coherence Tomography SystemPerimeter Medical Imaging, Inc. K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation SystemNinepoint Medical, Inc. K171560OTIS Optical Coherence Tomography SystemPerimeter Medical Imaging, 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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