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FDA 510(k)

SPY IMAGING SYSTEM

K-Number: K063345 · 2007-01-12

ApplicantNovadaq Technologies, Inc.
Decision Date2007-01-12
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SPY 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 2007-01-12 under 510(k) number K063345. 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 IMAGING SYSTEM?

SPY IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 2007-01-12. The listed applicant is Novadaq Technologies, Inc.. The 510(k) number is K063345.

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

SPY IMAGING SYSTEM received FDA 510(k) clearance on 2007-01-12, under 510(k) number K063345.

Who is the listed applicant for SPY 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 IMAGING SYSTEM?

The FDA product code for SPY IMAGING SYSTEM is IZI.

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Other records listing Novadaq Technologies, 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: 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.

K261037780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemStryker EndoscopyK253181SURGIMAGE SIM 1000H Fluorescence Imaging PlatformSurgimage CorporationK243645IC-Flow™ Imaging System 2.0Diagnostic Green GmbHK243077Affirm 800Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)K231986Modus IRSynaptive Medical, Inc.K234090EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)Surgvision GmbH

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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