FDA 510(k) clearance · back to tracker

ERGO IMAGING SYSTEM

Digirad Corp. cleared K100838 on 2010-04-23, decision: substantially equivalent

K-number

K100838

Sponsor

Digirad Corp.

Device

ERGO IMAGING SYSTEM

Class

Class I

Decision

Substantially Equivalent

Decision date

2010-04-23

Product code

IYX

Advisory committee

Radiology

Medical specialty

Radiology

Regulation number

892.1100

Official FDA record

Open K100838on 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 K100838 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.