FDA 510(k) clearance · back to tracker

InkSpace Imaging Small Body Array (SBA12PH30x)

Inkspace Imaging, Inc. cleared K253182 on 2025-10-20, decision: substantially equivalent

K-number

K253182

Sponsor

Inkspace Imaging, Inc.

Device

InkSpace Imaging Small Body Array (SBA12PH30x)

Class

Class II

Decision

Substantially Equivalent

Decision date

2025-10-20

Product code

MOS

Advisory committee

Radiology

Medical specialty

Radiology

Regulation number

892.1000

Official FDA record

Open K253182on accessdata.fda.gov →

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

openFDA JSON

Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

Use this as a predicate

Drop K253182 into Compass and start a substantial-equivalence draft.

Compass pulls the predicate's intended use, technological characteristics, and performance data, maps them against your device, and produces a draft SE table aligned to FDA's 510(k) program guidance.

Try the sandbox

Source

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