Atlas FDA

IXW

83 FDA 510(k) clearances · Product code

59 daysmedian time to decision
205 days90th percentile
83clearances measured

FDA profile

Official device name
Processor, Radiographic-Film, Automatic
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1900
Medical specialty
Radiology
Adverse events (MAUDE)
1995: 1 · 1996: 6 · 1997: 5 · 1998: 1 · 1999: 1 · 2000: 16
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
XTENDER FILM PROCESSOR, SPRINT FILM PROCESSOR MODEL XTENDER MODEL SPRINT (K111167)Velopex International, Inc.2011-08-18
INTRAX FILM PROCESSOR (K093503)Velopex International, Inc.2010-01-06
OPTIMAX, COMPACT 2, OPTIMAX 2010, ECOMAX (K091628)Protec GmbH & Co. KG2009-08-21
RADIOGRAPHIC FILM PROCESSOR, MODELS XP400 AND XP1000 (K024342)Daito Co., Ltd.2003-04-23
FILM PROCESSOR, MODEL LIFE RAY PRO 2500 (K023825)S.A.I.E.P. S.R.L.2003-02-12
FILM PROCESSOR, MODEL LIFE RAY PRO 1000 (K023801)S.A.I.E.P. S.R.L.2003-02-12
AX200 AUTOMATIC X-RAY FILM PROCESSOR, MODEL 6586.036 (K023613)Alphatek Corp.2003-01-23
LEVEL 356 X-RAY FILM PROCESSOR, MODELS MD & MD-D (K022154)Fischer Industries, Inc.2002-09-30
FREEDOM AUTOMATIC FILM PROCESSOR (K002640)J. Morita USA, Inc.2000-11-08
MICRO-MAX, MODEL 319 (K002404)Tek Marketing, Inc.2000-08-30
ALL-PRO 2010 (K001321)All-Pro Imaging Corp.2000-05-16
OPTIMAX/ COMPACT 2 (K992818)Protec GmbH & Co. KG1999-09-01
KONICA SRX- 701 AUTOMATIC X-RAY FILM PROCESSOR (K990969)Konica Medical Corp.1999-06-18
AII-PRO 100 PLUS AND ALL-PRO 200 (K991435)All-Pro Imaging Corp.1999-05-20
CP 1000, CURIX HT 330, CLASSIC E.O.S., CURIX HT 530, MAMORAY HT 300, MAMORAY CMPACT PLUS, CURIX COMPACT PLUS, CURIX COMS (K981280)Bayer Corp., Agfa Div.1998-04-30
MAMMOLOADER BY C.M.A. SRL (K973125)C.M.A.1997-10-08
KODAK MINILOADER(2000) (K970059)Eastman Kodak Company1997-01-27
3M TRIMATIC MODULAR ADVANCED PROCESSING SYSTEM AND 3M APS AUTOMATIC FILM PROCESSOR (K962750)Imation Corp.1996-08-21
JPI AUTOMATIC X-RAY FILM PROCESSOR (K955706)Jpi Healthcare Co, Ltd.1996-02-12
FUJI COMPUTED RADIOGRAPHY SYSTEM FCR9000HQ, FCR9501HQ (K951373)Fujifilm Medical System U.S.A., Inc.1995-10-27
KODAK AUTOMIXER II PLUS (K954484)Eastman Kodak Company1995-10-18
DOOSAN DSP 3800 AUTOMATIC X-RAY FILM PROCESSOR (K954345)Doosan Corp.1995-10-18
KODAK X-OMAT 3000 RA PROCESSOR (K951396)Eastman Kodak Company1995-05-15
KODAK X-OMAT 5000 RA PROCESSOR (K951397)Eastman Kodak Company1995-05-15
FUJI COMPUTED RADIOGRAPHY SYSTEMS (K944046)Fujifilm Medical System U.S.A., Inc.1995-05-11
JPI AUTOMATIC X-RAY FILM PROCESSOR (K950043)Jpi Healthcare Co, Ltd.1995-05-10
X-RAY FILM PROCESSOR (K940112)Fischer Industries, Inc.1995-04-11
KONICA SRX-201 AUTOMATIC X-RA FILM PROCESSOR (K950358)Storch Amini & Munves PC1995-03-17
VELO ACE (K940540)Emix U.S.A., Inc.1994-07-18
3M XP-2000 X-RAY FILM PROCESSOR (K940558)3M Company1994-03-22
KODAK X-OMAT M43A, M43, & CLINIC 1 PROCESSORS (K934350)Eastman Kodak Company1994-03-21
FUJI MEDICAL FILM PROCESSOR FPM2800 (K935957)Fujifilm Medical System U.S.A., Inc.1994-01-31
KONICA SRX-301 AUTOMATIC X-RAY FILM PROCESSOR (K931317)Konica Medical Corp.1993-12-14
KONICA SRX-501A AUTOMATIC X-RAY FILM PROCESSOR (K931315)Konica Medical Corp.1993-12-14
KONICA DS-7 AUTOMATIC X-RAY FILM PROCESSOR (K931316)Konica Medical Corp.1993-12-14
KODAK XML 300 DARKROOM FILM FEEDER (K933001)Eastman Kodak Company1993-09-28
KONICA QX-70 AUTOMATIC X-RAY FILM PROCESSOR (K931314)Konica Medical Corp.1993-09-07
KONICA SRX-101 AUTOMATIC X-RAY FILM PROCESSOR (K931312)Konica Medical Corp.1993-09-07
KONICA QX-130APLUS AUTOMATIC X-RAY FILM PROCESSOR (K931313)Konica Medical Corp.1993-09-07
MAMMO-300 AUTOMATIC X-RAY FILM PROCESSOR (K931882)Alphatek Corp.1993-08-23
AX-390SE AUTOMATIC X-RAY FILM PROCESSOR 9586.033 (K931883)Alphatek Corp.1993-08-23
FUJI DAYLIGHT CASSETTE MULTI-LOADER (K933408)Fujifilm Medical System U.S.A., Inc.1993-08-16
AFP 17 X 4 AUTOMATIC FILM PROCESSOR (K925885)Afp Imaging Corp.1993-06-09
KODAK EKTASCAN (K923554)Eastman Kodak Company1993-02-12
AX-700LE AUTOMATIC X-RAY FILM PROCESSOR (K925569)Alphatek Corp.1993-01-15
DU PONT COMPACT DAYLIGHT SYSTEM II (CDS II) (K924552)E.I. Dupont DE Nemours & Co., Inc.1992-12-07
AX-300SE AUTOMATIC X-RAY FILM PROCESSOR, 6586.027 (K924430)Alphatek Corp.1992-11-27
KODAK X-OMAT FS-1A PROCESSOR (K923552)Eastman Kodak Company1992-11-27
KODAK X-OMAT MODEL 180 LP PROCESSOR (K921269)Eastman Kodak Company1992-05-01
KODAK X-OMAT FIXER MANAGER (K920715)Eastman Kodak Company1992-04-27
KODAK X-OMAT 480 RA PROCESSOR (K914143)Eastman Kodak Company1992-01-06
KODAK EKTASCAN STORAGE PHOSPHOR READER MODEL 1A (K913354)Eastman Kodak Company1991-09-04
3M DIGITAL RECORDING AUTOMATIC FILM HANDLING UNIT (K912225)3M Medical Products Group1991-07-22
ALL-PRO 100 (K911291)All-Pro Imaging Corp.1991-07-03
KODAK 100-J & 100-K CHEMICAL MIXERS (K911713)Eastman Kodak Company1991-06-07
KODAK M35-MX-0MAT PROCESSOR (K911714)Eastman Kodak Company1991-06-07
KODAK AUTOMATIC FILM FEEDER, MODEL RA (K911711)Eastman Kodak Company1991-06-07
KODAK X-OMAT MULTILOADER 300 (K905607)Eastman Kodak Company1991-03-12
KODAK X-MAT 270 RA PROCESSOR (K904238)Eastman Kodak Company1990-10-03
KODAK X-OMAT 460 RA PROCESSOR (K902732)Eastman Kodak Company1990-08-17
KODAK M35A-M X-OMAT PROCESSOR (K901772)Eastman Kodak Company1990-07-25
MXR-14 FILM PROCESSOR (K890486)Cordell, Inc.1990-04-03
KODAK MULTILOADER 700 (K885207)Eastman Kodak Company1989-03-14
KODAK EKTASCAN LASER PRINTER ADAPTER, MODEL M6/M8 (K882320)Eastman Kodak Company1988-06-16
KODAK AUTOMATIC FILM FEEDER, MODEL 11 (K881248)Eastman Kodak Company1988-04-12
3M TRIMATIC M MODULAR SYSTEM AND ACCESSORIES (K880565)3M Company1988-03-21
3M XP515 X-RAY FILM PROCESSOR (K880563)3M Company1988-03-21
3M XP 505 X-RAY FILM PROCESSOR (K880564)3M Company1988-03-21
C900 X-RAY FILM PROCESSOR (K874908)Summit Industries, Inc.1988-02-12
KODAK REMOTE ALARM UNIT (K874926)Eastman Kodak Company1988-01-04
KODAK M35A X-OMAT PROCESSOR (K862595)Eastman Kodak Company1986-07-11
KODAK AUTOMIXER II (K861225)Eastman Kodak Company1986-04-07
KODAK X-OMAT PROCESSOR, MODEL ME-3 (K860666)Eastman Kodak Company1986-03-06
KODAK RP X-OMAT PROCESSOR MODEL M6B (K855219)Eastman Kodak Company1986-01-10
KODAK M35 X-OMAT PROCESSOR (K854219)Eastman Kodak Company1986-01-01
CURIX CAPACITY FILM CENTER (K832603)Agfa-Gevaert, Inc.1983-09-29
POLAROID RADIOGRAPHIC FILM PROCESSOR (K812088)Polaroid Corp.1981-08-31
KODAK MEDICAL X-RAY DEVELOPER & REPLEN. (K801209)Eastman Kodak Company1980-06-26
FILM-X 90 (K790121)Automatic Film Processor Corp.1979-02-21
PROCESSOR, MODEL M8 (K781934)Eastman Kodak Company1978-12-04
CRONEX QC-1 PROCESSOR (K780248)E.I. Dupont DE Nemours & Co., Inc.1978-03-02
AUTOMIXER, KODAK (K771857)Eastman Kodak Company1977-10-19
SUPERMAX AUTOMATIC X-RAY PROCESSOR (K760905)General Electric Co.1976-11-19

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