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FDA 510(k)

TRACTUS TISSUEMAPPER IMAGE RECORDING SYSTEM APPLICATION

K-Number: K131489 · 2013-06-25

ApplicantTractus Corporation
Decision Date2013-06-25
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TRACTUS TISSUEMAPPER IMAGE RECORDING SYSTEM APPLICATION is the device name listed in this FDA 510(k) record. The listed applicant is Tractus Corporation. It received FDA 510(k) clearance on 2013-06-25 under 510(k) number K131489. 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 TRACTUS TISSUEMAPPER IMAGE RECORDING SYSTEM APPLICATION?

TRACTUS TISSUEMAPPER IMAGE RECORDING SYSTEM APPLICATION is a medical device that received FDA 510(k) clearance on 2013-06-25. The listed applicant is Tractus Corporation. The 510(k) number is K131489.

When did TRACTUS TISSUEMAPPER IMAGE RECORDING SYSTEM APPLICATION receive FDA 510(k) clearance?

TRACTUS TISSUEMAPPER IMAGE RECORDING SYSTEM APPLICATION received FDA 510(k) clearance on 2013-06-25, under 510(k) number K131489.

Who is the listed applicant for TRACTUS TISSUEMAPPER IMAGE RECORDING SYSTEM APPLICATION?

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

What is the FDA product code for TRACTUS TISSUEMAPPER IMAGE RECORDING SYSTEM APPLICATION?

The FDA product code for TRACTUS TISSUEMAPPER IMAGE RECORDING SYSTEM APPLICATION is IYO.

Related Clinical Trials

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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Other records listing Tractus Corporation 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.

K123901TRACTUS TISSUEMAPPER REVIEWER APPLICATION

Related Devices (Code: IYO)

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.

K260313MD-6000S Bladder ScannerMEDA Co., Ltd.K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApSK252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT Scanner 2000 Model AQT Imaging Holdings, Inc.

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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