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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 the device name listed in this FDA 510(k) record. The listed applicant is Perimeter Medical Imaging, Inc.. It received FDA 510(k) clearance on 2016-05-13 under 510(k) 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. The listed applicant is Perimeter Medical Imaging, Inc.. The 510(k) number is K160240.

When did Perimeter Otis™ 1.0 Optical Coherence Tomography System receive FDA 510(k) clearance?

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

Who is the listed applicant for Perimeter Otis™ 1.0 Optical Coherence Tomography System?

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

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.

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Other records listing Perimeter Medical Imaging, 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.

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Related Devices (Code: NQQ)

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Official Source

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