IMAGCLEAR MAMMOGRAPHY REVIEW SYSTEM— 510(k) K992467

Name: FDA 510(k) clearance K992467
Creator: U.S. Food and Drug Administration
Published: 2000-02-10

Substantially Equivalent

Dba Systems, Inc.

FDA 510(k) clearance K992467 for IMAGCLEAR MAMMOGRAPHY REVIEW SYSTEM, Substantially Equivalent on 2000-02-10. Applicant: Dba Systems, Inc.. Device class: 2.

Clearance details

Applicant: Dba Systems, Inc.
Product code: Code LMA
Device class: Class 2
Regulation: 21 CFR 892.2030
Advisory panel: Radiology
Date received: 1999-07-23
Decision date: 2000-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LMA

view all

K132183 — DICOM VIDEO2013-10-03
K130636 — TELERADPRO EDGE; TELERADPRO EDGE HD-CCD2013-06-07
K130406 — DIAGNOSTICPRO EDGE2013-04-29
K102476 — TELERADPRO2010-10-07
K093809 — VIDAR DENTAL FILM DIGITIZER2010-01-07

More clearances from Dba Systems, Inc.

view all

K932760 — DFS-21001994-10-20

Data sourced from openFDA. This site is unofficial and independent of the FDA.