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FDA 510(k)

HDH Treatment Planning System

K-Number: K212173 · 2022-01-25

Decision Date2022-01-25
Product CodePNN
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HDH Treatment Planning System is the device name listed in this FDA 510(k) record. The listed applicant is Cdb Corporation. It received FDA 510(k) clearance on 2022-01-25 under 510(k) number K212173. The device is classified under product code PNN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HDH Treatment Planning System?

HDH Treatment Planning System is a medical device that received FDA 510(k) clearance on 2022-01-25. The listed applicant is Cdb Corporation. The 510(k) number is K212173.

When did HDH Treatment Planning System receive FDA 510(k) clearance?

HDH Treatment Planning System received FDA 510(k) clearance on 2022-01-25, under 510(k) number K212173.

Who is the listed applicant for HDH Treatment Planning System?

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

What is the FDA product code for HDH Treatment Planning System?

The FDA product code for HDH Treatment Planning System is PNN.

Other records listing Cdb Corporation 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: PNN)

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.