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Echo. Akho

FDA 510(k)

Class II (US FDA 510(k))

510(k) K951976

by Alliance Medical, Inc.

Identifiers

510(k) Number
K951976 FDA 510(k)
FDA Product Code
IYO FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1560 FDA 510(k)
Regulation Number
892.1560 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Echo. Akho is an ultrasound system manufactured by Alliance Medical, Inc. This device is designed for diagnostic imaging applications in medical settings.

The Echo. Akho is supplied by Alliance Medical, Inc. and received FDA 510(k) clearance on July 26, 1996. The device is authorized under product code IYO and was reviewed by the Radiology advisory committee. No information regarding sterility, single-use status, MRI safety, or storage conditions is provided in the device data.

Frequently asked questions

What is the Echo. Akho ultrasound system used for?

The Echo. Akho is designed for diagnostic imaging applications in medical settings. It is manufactured by Alliance Medical, Inc. and received FDA 510(k) clearance on July 26, 1996.

What are the regulatory details for the Echo. Akho system?

The Echo. Akho received FDA 510(k) clearance on July 26, 1996, under product code IYO. It was reviewed by the Radiology advisory committee and determined to be substantially equivalent.

Is the Echo. Akho system sterile or single-use?

The device data does not provide information regarding sterility or single-use status for the Echo. Akho ultrasound system.

Who manufactures the Echo. Akho ultrasound system?

The Echo. Akho ultrasound system is manufactured by Alliance Medical, Inc., located at 3610 Valiquette St., St-Laurent, Quebec, Canada.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ECHO. AKHO by ALLIANCE MEDICAL, INC. | FDA 510(k) Summary, K951976 FDA 510 (k) - ECHO. AKHO | Alliance Medical, Inc., Alliance Echo. Akho - allmed.wiki, ECHO. AKHO (K951976) — FDA 510 (k) | Innolitics, Echo. Akho 510 (k) FDA Premarket Notification K951976 ALLIANCE MEDICAL ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Alliance Medical, Inc.

Sources (1)

  • FDA 510(k) K951976 24 fields · synced Oct 6, 2026