Cleared Traditional

MD-1835

K964806 · Fischer Imaging Corp. · Radiology
Mar 1997
Decision
95d
Days
Class 2
Risk

About This 510(k) Submission

K964806 is an FDA 510(k) clearance for the MD-1835, a Device, Spot-film (Class II — Special Controls, product code IXL), submitted by Fischer Imaging Corp. (Addison, US). The FDA issued a Cleared decision on March 4, 1997, 95 days after receiving the submission on November 29, 1996. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1670.

Submission Details

510(k) Number K964806 FDA.gov
FDA Decision Cleared SESE
Date Received November 29, 1996
Decision Date March 04, 1997
Days to Decision 95 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

Device Classification

Product Code IXL — Device, Spot-film
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1670

Similar Devices — IXL Device, Spot-film

All 12
OPTIMA XR120
K111304 · Ge Medical Systems, LLC · Jul 2011
ADVANTX 1824 SPOTFILM DEVICE
K950317 · GE Medical Systems · Feb 1995
KODAK AUTOMIXER III INTEGRATED, KODAK AUTOMIXER III 180 LP
K940386 · Eastman Kodak Company · Aug 1994
AXT 1400 SPOTFILM DEVICE
K942367 · Applied X-Ray Technologies, Inc. · Jun 1994
DIAGNOST 76 FAMILY*R/F SYSTEMS - RELEASE 4.4
K924593 · Philips Medical Systems, Inc. · Nov 1992
ELITE R/F SPOT FILM DRIVE
K902403 · Rms Div. · Aug 1990