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FDA 510(k)

ILAB ULTRASOUND IMAGING SYSTEM

K-Number: K123535 · 2013-01-15

ApplicantBoston Scientific Corp
Decision Date2013-01-15
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ILAB ULTRASOUND IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 2013-01-15 under 510(k) number K123535. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ILAB ULTRASOUND IMAGING SYSTEM?

ILAB ULTRASOUND IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 2013-01-15. The listed applicant is Boston Scientific Corp. The 510(k) number is K123535.

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

ILAB ULTRASOUND IMAGING SYSTEM received FDA 510(k) clearance on 2013-01-15, under 510(k) number K123535.

Who is the listed applicant for ILAB ULTRASOUND IMAGING SYSTEM?

The FDA 510(k) record lists Boston Scientific Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ILAB ULTRASOUND IMAGING SYSTEM?

The FDA product code for ILAB ULTRASOUND IMAGING SYSTEM is IYO.

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Related Devices (Code: IYO)

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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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