FDA 510(k)

PROSOUND F37 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL: PROSOUND F37

K-Number: K122341 · 2012-09-26

Decision Date2012-09-26

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

PROSOUND F37 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL: PROSOUND F37 is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi Aloka Medical, Ltd.. It received FDA 510(k) clearance on 2012-09-26 under 510(k) number K122341. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROSOUND F37 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL: PROSOUND F37?

PROSOUND F37 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL: PROSOUND F37 is a medical device that received FDA 510(k) clearance on 2012-09-26. The listed applicant is Hitachi Aloka Medical, Ltd.. The 510(k) number is K122341.

When did PROSOUND F37 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL: PROSOUND F37 receive FDA 510(k) clearance?

PROSOUND F37 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL: PROSOUND F37 received FDA 510(k) clearance on 2012-09-26, under 510(k) number K122341.

Who is the listed applicant for PROSOUND F37 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL: PROSOUND F37?

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

What is the FDA product code for PROSOUND F37 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL: PROSOUND F37?

The FDA product code for PROSOUND F37 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL: PROSOUND F37 is IYN.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.