LD2000 SERIES— 510(k) K980565

Substantially Equivalent

General Scanning, Inc.

FDA 510(k) clearance K980565 for LD2000 SERIES, Substantially Equivalent on 1998-03-19. Applicant: General Scanning, Inc.. Device class: 2.

Clearance details

Applicant: General Scanning, Inc.
Product code: Code LMA
Device class: Class 2
Regulation: 21 CFR 892.2030
Advisory panel: Radiology
Date received: 1998-02-13
Decision date: 1998-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Watertown, MA, US

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 General Scanning, Inc.

K973411 — DIGMI-2000 (GSI INTERNAL REFERENCE)/LD2800 (MARKETING NAME)1997-12-04
K923536 — NUCLEAR MEDICINE LASER IMAGER1992-11-30

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