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FDA 510(k)

MODEL VIAMO SSA-640A, VERSION 2.0 ULTRASOUND SYSTEM

K-Number: K100067 · 2010-01-28

ApplicantToshiba America Medical Systems, In.C
Decision Date2010-01-28
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MODEL VIAMO SSA-640A, VERSION 2.0 ULTRASOUND SYSTEM 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 2010-01-28 under 510(k) number K100067. 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 MODEL VIAMO SSA-640A, VERSION 2.0 ULTRASOUND SYSTEM?

MODEL VIAMO SSA-640A, VERSION 2.0 ULTRASOUND SYSTEM is a medical device that received FDA 510(k) clearance on 2010-01-28. The listed applicant is Toshiba America Medical Systems, In.C. The 510(k) number is K100067.

When did MODEL VIAMO SSA-640A, VERSION 2.0 ULTRASOUND SYSTEM receive FDA 510(k) clearance?

MODEL VIAMO SSA-640A, VERSION 2.0 ULTRASOUND SYSTEM received FDA 510(k) clearance on 2010-01-28, under 510(k) number K100067.

Who is the listed applicant for MODEL VIAMO SSA-640A, VERSION 2.0 ULTRASOUND SYSTEM?

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 MODEL VIAMO SSA-640A, VERSION 2.0 ULTRASOUND SYSTEM?

The FDA product code for MODEL VIAMO SSA-640A, VERSION 2.0 ULTRASOUND SYSTEM 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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