FDA 510(k) clearance · back to tracker

POWERMAT VRP-1 X-RAY IMAGING

Powers Chemco, Inc. cleared K840698 on 1984-03-16, decision: substantially equivalent

K-number

K840698

Sponsor

Powers Chemco, Inc.

Device

POWERMAT VRP-1 X-RAY IMAGING

Class

Class I

Decision

Substantially Equivalent

Decision date

1984-03-16

Product code

IWZ

Advisory committee

Radiology

Medical specialty

Radiology

Regulation number

892.1840

Official FDA record

Open K840698on 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 K840698 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.