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FDA 510(k)

Smart Stitching Software System, Image Processing, Radiological

K-Number: K163048 · 2017-07-28

ApplicantOsko, Inc.
Decision Date2017-07-28
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Smart Stitching Software System, Image Processing, Radiological is the device name listed in this FDA 510(k) record. The listed applicant is Osko, Inc.. It received FDA 510(k) clearance on 2017-07-28 under 510(k) number K163048. 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 Smart Stitching Software System, Image Processing, Radiological?

Smart Stitching Software System, Image Processing, Radiological is a medical device that received FDA 510(k) clearance on 2017-07-28. The listed applicant is Osko, Inc.. The 510(k) number is K163048.

When did Smart Stitching Software System, Image Processing, Radiological receive FDA 510(k) clearance?

Smart Stitching Software System, Image Processing, Radiological received FDA 510(k) clearance on 2017-07-28, under 510(k) number K163048.

Who is the listed applicant for Smart Stitching Software System, Image Processing, Radiological?

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

What is the FDA product code for Smart Stitching Software System, Image Processing, Radiological?

The FDA product code for Smart Stitching Software System, Image Processing, Radiological is LLZ.

Related Clinical Trials

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Other records listing Osko, Inc. as applicant

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Related Devices (Code: LLZ)

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Official Source

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