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FDA 510(k)

SPY INTRA-OPERATIVE IMAGING SYSTEM

K-Number: K100371 · 2011-02-04

ApplicantNovadaq Technologies, Inc.
Decision Date2011-02-04
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SPY INTRA-OPERATIVE IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Novadaq Technologies, Inc.. It received FDA 510(k) clearance on 2011-02-04 under 510(k) number K100371. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPY INTRA-OPERATIVE IMAGING SYSTEM?

SPY INTRA-OPERATIVE IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 2011-02-04. The listed applicant is Novadaq Technologies, Inc.. The 510(k) number is K100371.

When did SPY INTRA-OPERATIVE IMAGING SYSTEM receive FDA 510(k) clearance?

SPY INTRA-OPERATIVE IMAGING SYSTEM received FDA 510(k) clearance on 2011-02-04, under 510(k) number K100371.

Who is the listed applicant for SPY INTRA-OPERATIVE IMAGING SYSTEM?

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

What is the FDA product code for SPY INTRA-OPERATIVE IMAGING SYSTEM?

The FDA product code for SPY INTRA-OPERATIVE IMAGING SYSTEM is IZI.

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Related Devices (Code: IZI)

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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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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