FDA 510(k)

RA-I

K-Number: K781642 · 1978-10-10

Decision Date1978-10-10

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

RA-I is the device name listed in this FDA 510(k) record. The listed applicant is Diasonics, Inc.. It received FDA 510(k) clearance on 1978-10-10 under 510(k) number K781642. 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 RA-I?

RA-I is a medical device that received FDA 510(k) clearance on 1978-10-10. The listed applicant is Diasonics, Inc.. The 510(k) number is K781642.

When did RA-I receive FDA 510(k) clearance?

RA-I received FDA 510(k) clearance on 1978-10-10, under 510(k) number K781642.

Who is the listed applicant for RA-I?

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

What is the FDA product code for RA-I?

The FDA product code for RA-I is IYN.

Other records listing Diasonics, 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.

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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.