Cleared Traditional

MODIFICATION TO LR 5200 FILM RECORDER

K012010 · Agfa Corp. · Radiology
Sep 2001
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K012010 is an FDA 510(k) clearance for the MODIFICATION TO LR 5200 FILM RECORDER, a Camera, Multi Format, Radiological (Class II — Special Controls, product code LMC), submitted by Agfa Corp. (Rockville, US). The FDA issued a Cleared decision on September 20, 2001, 85 days after receiving the submission on June 27, 2001. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2040.

Submission Details

510(k) Number K012010 FDA.gov
FDA Decision Cleared SESE
Date Received June 27, 2001
Decision Date September 20, 2001
Days to Decision 85 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LMC — Camera, Multi Format, Radiological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2040

Similar Devices — LMC Camera, Multi Format, Radiological

All 120
SONY HYBIRD GRAPHIC UP-971AD, SONY HYBIRD GRAPHIC PRINTER UP-991AD
K141346 · Sony Electronics, Inc. · Jun 2014
SONY DIGITAL PRINTER UP-D898MD/SONY HYBRID PRINTER UP-X898MD
K141454 · Sony Electronics, Inc. · Jun 2014
DRYVIEW CHROMA IMAGING SYSTEM
K111566 · Carestream Health, Inc. · Oct 2011
CYPHER DICOM PRINT SOLUTION
K092280 · Virtual Imaging, Inc. · Oct 2009
CARESTREAM DRYVIEW 5850 LASER IMAGER
K090469 · Carestream Health, Inc. · May 2009
SONY UP-DF750 DIGITAL FILM IMAGER
K083522 · Sony Electronics, Inc. · Jan 2009