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FDA 510(k)

ALOKA SSD-ALPHA 7 ULTRASOUND SYSTEM

K-Number: K072285 · 2007-08-30

ApplicantAloka Co., Ltd.
Decision Date2007-08-30
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ALOKA SSD-ALPHA 7 ULTRASOUND SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Aloka Co., Ltd.. It received FDA 510(k) clearance on 2007-08-30 under 510(k) number K072285. 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 ALOKA SSD-ALPHA 7 ULTRASOUND SYSTEM?

ALOKA SSD-ALPHA 7 ULTRASOUND SYSTEM is a medical device that received FDA 510(k) clearance on 2007-08-30. The listed applicant is Aloka Co., Ltd.. The 510(k) number is K072285.

When did ALOKA SSD-ALPHA 7 ULTRASOUND SYSTEM receive FDA 510(k) clearance?

ALOKA SSD-ALPHA 7 ULTRASOUND SYSTEM received FDA 510(k) clearance on 2007-08-30, under 510(k) number K072285.

Who is the listed applicant for ALOKA SSD-ALPHA 7 ULTRASOUND SYSTEM?

The FDA 510(k) record lists Aloka Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ALOKA SSD-ALPHA 7 ULTRASOUND SYSTEM?

The FDA product code for ALOKA SSD-ALPHA 7 ULTRASOUND SYSTEM is ITX.

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Other records listing Aloka Co., Ltd. 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.

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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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