FDA 510(k) clearance · back to tracker

SmartCT (R3.0 (L10))

Philips Medical Systems B.V. cleared K253670 on 2026-07-10, decision: substantially equivalent

K-number

K253670

Sponsor

Philips Medical Systems B.V.

Device

SmartCT (R3.0 (L10))

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-07-10

Product code

OWB

Advisory committee

Radiology

Medical specialty

Radiology

Regulation number

892.1650

Official FDA record

Open K253670on 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 K253670 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.