FDA 510(k) clearance · back to tracker

STANDARD IMAGING PIPSPRO QA SOFTWARE SYSTEM

Standard Imaging, Inc. cleared K042733 on 2004-11-15, decision: substantially equivalent

K-number

K042733

Sponsor

Standard Imaging, Inc.

Device

STANDARD IMAGING PIPSPRO QA SOFTWARE SYSTEM

Class

Class I

Decision

Substantially Equivalent

Decision date

2004-11-15

Product code

LHO

Advisory committee

Radiology

Medical specialty

Radiology

Regulation number

892.1940

Official FDA record

Open K042733on 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 K042733 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.