EFILM VIDEO— 510(k) K013631

Substantially Equivalent

Efilm Medical, Inc.

FDA 510(k) clearance K013631 for EFILM VIDEO, Substantially Equivalent on 2001-11-20. Applicant: Efilm Medical, Inc.. Device class: 2.

Clearance details

Applicant: Efilm Medical, Inc.
Product code: Code LMA
Device class: Class 2
Regulation: 21 CFR 892.2030
Advisory panel: Radiology
Date received: 2001-11-05
Decision date: 2001-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Toronto, Ontario, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code LMA

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 Efilm Medical, Inc.

K020995 — EFILM WORKSTATION WITH MODULES2002-04-12
K012211 — EFILM WORKSTATION2001-07-31

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