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FDA 510(k)

PHASED ARRAY TRANSDUCER - - PSK-20CT

K-Number: K970047 · 1997-03-04

ApplicantToshiba America Medical Systems, In.C
Decision Date1997-03-04
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PHASED ARRAY TRANSDUCER - - PSK-20CT is the device name listed in this FDA 510(k) record. The listed applicant is Toshiba America Medical Systems, In.C. It received FDA 510(k) clearance on 1997-03-04 under 510(k) number K970047. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHASED ARRAY TRANSDUCER - - PSK-20CT?

PHASED ARRAY TRANSDUCER - - PSK-20CT is a medical device that received FDA 510(k) clearance on 1997-03-04. The listed applicant is Toshiba America Medical Systems, In.C. The 510(k) number is K970047.

When did PHASED ARRAY TRANSDUCER - - PSK-20CT receive FDA 510(k) clearance?

PHASED ARRAY TRANSDUCER - - PSK-20CT received FDA 510(k) clearance on 1997-03-04, under 510(k) number K970047.

Who is the listed applicant for PHASED ARRAY TRANSDUCER - - PSK-20CT?

The FDA 510(k) record lists Toshiba America Medical Systems, In.C as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PHASED ARRAY TRANSDUCER - - PSK-20CT?

The FDA product code for PHASED ARRAY TRANSDUCER - - PSK-20CT is ITX.

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Related Devices (Code: ITX)

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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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