FDA 510(k) clearance · back to tracker

InkSpace Imaging Body Array

Inkspace Imaging, Inc. cleared K223487 on 2022-12-08, decision: substantially equivalent

K-number

K223487

Sponsor

Inkspace Imaging, Inc.

Device

InkSpace Imaging Body Array

Class

Class II

Decision

Substantially Equivalent

Decision date

2022-12-08

Product code

MOS

Advisory committee

Radiology

Medical specialty

Radiology

Regulation number

892.1000

Official FDA record

Open K223487on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.