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FDA 510(k)

OPART/PRODIGA, OPART/PROTENZA, OPART/PARAGON

K-Number: K993574 · 2000-01-18

ApplicantToshiba America Mri, Inc.
Decision Date2000-01-18
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OPART/PRODIGA, OPART/PROTENZA, OPART/PARAGON is the device name listed in this FDA 510(k) record. The listed applicant is Toshiba America Mri, Inc.. It received FDA 510(k) clearance on 2000-01-18 under 510(k) number K993574. 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 OPART/PRODIGA, OPART/PROTENZA, OPART/PARAGON?

OPART/PRODIGA, OPART/PROTENZA, OPART/PARAGON is a medical device that received FDA 510(k) clearance on 2000-01-18. The listed applicant is Toshiba America Mri, Inc.. The 510(k) number is K993574.

When did OPART/PRODIGA, OPART/PROTENZA, OPART/PARAGON receive FDA 510(k) clearance?

OPART/PRODIGA, OPART/PROTENZA, OPART/PARAGON received FDA 510(k) clearance on 2000-01-18, under 510(k) number K993574.

Who is the listed applicant for OPART/PRODIGA, OPART/PROTENZA, OPART/PARAGON?

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

What is the FDA product code for OPART/PRODIGA, OPART/PROTENZA, OPART/PARAGON?

The FDA product code for OPART/PRODIGA, OPART/PROTENZA, OPART/PARAGON is LNH.

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Other records listing Toshiba America Mri, 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: 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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