FDA 510(k)

Perimeter Otis 1.0 Optical Coherence Tomography System

K-Number: K160240 · 2016-05-13

ApplicantPerimeter Medical Imaging, Inc.

Decision Date2016-05-13

Product CodeNQQ

Advisory CommitteeRA

DecisionUnknown

Device Summary

Perimeter Otis 1.0 Optical Coherence Tomography System is a medical device manufactured by Perimeter Medical Imaging, Inc.. It received FDA 510(k) clearance on 2016-05-13 under approval number K160240. The device is classified under product code NQQ. It was reviewed by the RA advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the Perimeter Otis 1.0 Optical Coherence Tomography System?

Perimeter Otis 1.0 Optical Coherence Tomography System is a medical device that received FDA 510(k) clearance on 2016-05-13. It is manufactured by Perimeter Medical Imaging, Inc.. The 510(k) number is K160240.

When was Perimeter Otis 1.0 Optical Coherence Tomography System approved by the FDA?

Perimeter Otis 1.0 Optical Coherence Tomography System received FDA 510(k) clearance on 2016-05-13, under approval number K160240.

What company makes Perimeter Otis 1.0 Optical Coherence Tomography System?

Perimeter Otis 1.0 Optical Coherence Tomography System is manufactured by Perimeter Medical Imaging, Inc..

What is the FDA product code for Perimeter Otis 1.0 Optical Coherence Tomography System?

The FDA product code for Perimeter Otis 1.0 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, Inc.

K171560OTIS Optical Coherence Tomography System K190404OTIS Optical Coherence Tomography SYstem

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. 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. K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.

Official Source

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