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FDA 510(k)

PET-512MC TRANSESOPHAGEAL TRANSDUCER

K-Number: K103629 · 2011-02-02

ApplicantToshiba America Medical Systems, In.C
Decision Date2011-02-02
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PET-512MC TRANSESOPHAGEAL TRANSDUCER 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 2011-02-02 under 510(k) number K103629. 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 PET-512MC TRANSESOPHAGEAL TRANSDUCER?

PET-512MC TRANSESOPHAGEAL TRANSDUCER is a medical device that received FDA 510(k) clearance on 2011-02-02. The listed applicant is Toshiba America Medical Systems, In.C. The 510(k) number is K103629.

When did PET-512MC TRANSESOPHAGEAL TRANSDUCER receive FDA 510(k) clearance?

PET-512MC TRANSESOPHAGEAL TRANSDUCER received FDA 510(k) clearance on 2011-02-02, under 510(k) number K103629.

Who is the listed applicant for PET-512MC TRANSESOPHAGEAL TRANSDUCER?

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 PET-512MC TRANSESOPHAGEAL TRANSDUCER?

The FDA product code for PET-512MC TRANSESOPHAGEAL TRANSDUCER is 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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