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FDA 510(k)

IG4 IMAGE GUIDED SYSTEM, MODEL: SYS-0200

K-Number: K093146 · 2009-11-30

ApplicantVeran Medical Technologies, Inc.
Decision Date2009-11-30
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IG4 IMAGE GUIDED SYSTEM, MODEL: SYS-0200 is the device name listed in this FDA 510(k) record. The listed applicant is Veran Medical Technologies, Inc.. It received FDA 510(k) clearance on 2009-11-30 under 510(k) number K093146. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IG4 IMAGE GUIDED SYSTEM, MODEL: SYS-0200?

IG4 IMAGE GUIDED SYSTEM, MODEL: SYS-0200 is a medical device that received FDA 510(k) clearance on 2009-11-30. The listed applicant is Veran Medical Technologies, Inc.. The 510(k) number is K093146.

When did IG4 IMAGE GUIDED SYSTEM, MODEL: SYS-0200 receive FDA 510(k) clearance?

IG4 IMAGE GUIDED SYSTEM, MODEL: SYS-0200 received FDA 510(k) clearance on 2009-11-30, under 510(k) number K093146.

Who is the listed applicant for IG4 IMAGE GUIDED SYSTEM, MODEL: SYS-0200?

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

What is the FDA product code for IG4 IMAGE GUIDED SYSTEM, MODEL: SYS-0200?

The FDA product code for IG4 IMAGE GUIDED SYSTEM, MODEL: SYS-0200 is JAK.

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Other records listing Veran Medical Technologies, Inc. as applicant

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Related Devices (Code: JAK)

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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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