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FDA 510(k)

E-SCAN MRI SYSTEM

K-Number: K012728 · 2001-08-29

ApplicantBiosound Esaote, Inc.
Decision Date2001-08-29
Product CodeMOS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

E-SCAN MRI SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Biosound Esaote, Inc.. It received FDA 510(k) clearance on 2001-08-29 under 510(k) number K012728. The device is classified under product code MOS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the E-SCAN MRI SYSTEM?

E-SCAN MRI SYSTEM is a medical device that received FDA 510(k) clearance on 2001-08-29. The listed applicant is Biosound Esaote, Inc.. The 510(k) number is K012728.

When did E-SCAN MRI SYSTEM receive FDA 510(k) clearance?

E-SCAN MRI SYSTEM received FDA 510(k) clearance on 2001-08-29, under 510(k) number K012728.

Who is the listed applicant for E-SCAN MRI SYSTEM?

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

What is the FDA product code for E-SCAN MRI SYSTEM?

The FDA product code for E-SCAN MRI SYSTEM is MOS.

Related Clinical Trials

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Other records listing Biosound Esaote, 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.

K023255TECHNOS MP, MODEL AU6K014168AU6 (TECHNOS/TECHNOS MP) ULTRASOUND IMAGING SYSTEM (ADDITION OF 3D IMAGING MODE AND MUSCULOSKELETAL INDICATION)K020164E-SCAN XQK0104057230 ULTRASOUND IMAGING SYSTEM WITH TEIK010057MODIFICATION TO ARTOSCAN MK001894MODIFICATION TO E-SCAN

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Related Devices (Code: MOS)

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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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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