Atlas FDA

IWZ

34 FDA 510(k) clearances · Product code

52 daysmedian time to decision
102 days90th percentile
34clearances measured

FDA profile

Official device name
Film, Radiographic
Device class
Class I (low risk)
Regulation
21 CFR 892.1840
Medical specialty
Radiology
Adverse events (MAUDE)
1996: 3 · 1998: 1 · 2000: 1 · 2002: 1 · 2004: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
KODAK EKTASIAN HG FILM (EHG-15) (K970154)Eastman Kodak Company1997-04-04
VOXGRAM (K954200)Voxel1995-09-29
3M MEDICAL DIAGNOSTIC VIDEOCASSETTE (K931604)3M Health Care, Ltd.1993-07-21
3M MEDICAL DIAGNOSTIC SUPER VHS VIDEOCASSETTE (K931605)3M Health Care, Ltd.1993-07-20
ORWO X-RAY FILM (K920539)Burkhart Roentgen Intl., Inc.1992-06-30
KODAK DENTAL BARRIER PAC (K884827)Eastman Kodak Company1989-01-30
KODAK CFT FILM SO-141 (K862944)Eastman Kodak Company1986-08-12
TYPE 633 COMPUTED RADIOGRAPHY (CR) FILM (K862415)Parexel Intl. Corp.1986-07-01
MEDICAL X-RAY FILM (K860797)India-America Trading Co.1986-03-13
BELMONT AUTOPAN-PANORAMIC 098 CEPHALOMETRIC-RADIOG (K844554)Belmont Equipment Corp.1985-02-21
FR MEDICAL X-RAY FILM (K840806)Fr Medical/Fr Chemicals1984-04-24
POWERMAT VRP-1 X-RAY IMAGING (K840698)Powers Chemco, Inc.1984-03-16
WILCOR-XR RP MEDICAL FILM (K834613)Cea America Corp.1984-03-05
WILCOR-XR RP-L MEDICAL FILM (K834614)Cea America Corp.1984-03-05
WILCOR-XR RP-OG MEDICAL FILM (K834612)Cea America Corp.1984-02-27
SINGUL-XR RP NON SCREEN MED. FILM (K834611)Cea America Corp.1984-02-21
KODAK T-MAT L FILM SO-387 (K833234)Eastman Kodak Company1983-10-28
CRONEX LO-DOSE MAMMOGRAPHY (K832504)E.I. Dupont DE Nemours & Co., Inc.1983-09-12
KODAK CINEFLUOROGRAPHIC FILM SO-274 (K813005)Eastman Kodak Company1981-11-24
POLAROID TPX RADIOGRAPHIC FILM (K811352)Polaroid Corp.1981-06-18
KODAK ORTHO L FILM (K802171)Eastman Kodak Company1980-10-31
KODAK EKTASPEED DENTAL X-RAY FILM (K800901)Eastman Kodak Company1980-05-20
HOPE MODEL 126, AUTO/PROCES., DEN. FLM (K800134)Hope Industries, Inc.1980-05-02
KODAK X-OMAT RP FILM (K792517)Eastman Kodak Company1980-01-09
KODAK CFN FILM SO-224 (K792178)Eastman Kodak Company1980-01-09
KODAK X-OMAT M20 PROCESSOR, MODEL 2 (K792434)Eastman Kodak Company1980-01-09
SR 301 MEDICAL X-RAY FILM (K792317)E.I. Dupont DE Nemours & Co., Inc.1980-01-09
KODAK X-OMAT G FILM (K792448)Eastman Kodak Company1980-01-09
KODAK X-OMAT M20 PROCESSOR, MODEL 1 (K792435)Eastman Kodak Company1980-01-09
KODAK ORTHO G FILM (K792293)Eastman Kodak Company1980-01-09
KODAK ORTHO M FILM (K791360)Eastman Kodak Company1979-09-04
KODAK GRAY TONE IMAGING FILM (K790629)Eastman Kodak Company1979-04-23
ORTHO H FILM (K771681)Eastman Kodak Company1977-09-14
GRAY TONE IMAGING FILM (K771223)Eastman Kodak Company1977-07-14

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