PowerLook Density Assessment V4.0
K-Number: K211506 · 2021-07-12
Device Summary
Frequently Asked Questions
What is the PowerLook Density Assessment V4.0?
PowerLook Density Assessment V4.0 is a medical device that received FDA 510(k) clearance on 2021-07-12. The listed applicant is Icad, Inc.. The 510(k) number is K211506.
When did PowerLook Density Assessment V4.0 receive FDA 510(k) clearance?
PowerLook Density Assessment V4.0 received FDA 510(k) clearance on 2021-07-12, under 510(k) number K211506.
Who is the listed applicant for PowerLook Density Assessment V4.0?
The FDA 510(k) record lists Icad, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for PowerLook Density Assessment V4.0?
The FDA product code for PowerLook Density Assessment V4.0 is QIH.
Other records listing Icad, 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: QIH)
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
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.