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FDA 510(k)

RADSTAT

K-Number: K932564 · 1994-03-16

Decision Date1994-03-16
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RADSTAT is the device name listed in this FDA 510(k) record. The listed applicant is Dimensional Medicine, Inc.. It received FDA 510(k) clearance on 1994-03-16 under 510(k) number K932564. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RADSTAT?

RADSTAT is a medical device that received FDA 510(k) clearance on 1994-03-16. The listed applicant is Dimensional Medicine, Inc.. The 510(k) number is K932564.

When did RADSTAT receive FDA 510(k) clearance?

RADSTAT received FDA 510(k) clearance on 1994-03-16, under 510(k) number K932564.

Who is the listed applicant for RADSTAT?

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

What is the FDA product code for RADSTAT?

The FDA product code for RADSTAT is LLZ.

Related Clinical Trials

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.

Other records listing Dimensional Medicine, 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.

Related Devices (Code: LLZ)

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.

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.

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