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FDA 510(k)

1.5T EDGE AND 1.0T VISTA SYSTEMS

K-Number: K931544 · 1993-11-22

ApplicantPhilips Medical Systems (Cleveland), Inc.
Decision Date1993-11-22
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

1.5T EDGE AND 1.0T VISTA SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems (Cleveland), Inc.. It received FDA 510(k) clearance on 1993-11-22 under 510(k) number K931544. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 1.5T EDGE AND 1.0T VISTA SYSTEMS?

1.5T EDGE AND 1.0T VISTA SYSTEMS is a medical device that received FDA 510(k) clearance on 1993-11-22. The listed applicant is Philips Medical Systems (Cleveland), Inc.. The 510(k) number is K931544.

When did 1.5T EDGE AND 1.0T VISTA SYSTEMS receive FDA 510(k) clearance?

1.5T EDGE AND 1.0T VISTA SYSTEMS received FDA 510(k) clearance on 1993-11-22, under 510(k) number K931544.

Who is the listed applicant for 1.5T EDGE AND 1.0T VISTA SYSTEMS?

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

What is the FDA product code for 1.5T EDGE AND 1.0T VISTA SYSTEMS?

The FDA product code for 1.5T EDGE AND 1.0T VISTA SYSTEMS is LNH.

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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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