Product code IXW
- Device name
- Processor, Radiographic-Film, Automatic
- Medical specialty
- Radiology
- Device class
- 2
- Regulation number
- 892.1900
- Review panel
- RA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K111167 | XTENDER FILM PROCESSOR, SPRINT FILM PROCESSOR MODEL XTENDER MODEL SPRINT | Velopex International, Inc. | 2011-08-18 |
| K093503 | INTRAX FILM PROCESSOR | Velopex International, Inc. | 2010-01-06 |
| K091628 | OPTIMAX, COMPACT 2, OPTIMAX 2010, ECOMAX | Protec GmbH & Co. KG | 2009-08-21 |
| K024342 | RADIOGRAPHIC FILM PROCESSOR, MODELS XP400 AND XP1000 | Daito Co., Ltd. | 2003-04-23 |
| K023801 | FILM PROCESSOR, MODEL LIFE RAY PRO 1000 | S.A.I.E.P. S.R.L. | 2003-02-12 |
| K023825 | FILM PROCESSOR, MODEL LIFE RAY PRO 2500 | S.A.I.E.P. S.R.L. | 2003-02-12 |
| K023613 | AX200 AUTOMATIC X-RAY FILM PROCESSOR, MODEL 6586.036 | Alphatek Corp. | 2003-01-23 |
| K022154 | LEVEL 356 X-RAY FILM PROCESSOR, MODELS MD & MD-D | Fischer Industries, Inc. | 2002-09-30 |
| K002640 | FREEDOM AUTOMATIC FILM PROCESSOR | J. Morita USA, Inc. | 2000-11-08 |
| K002404 | MICRO-MAX, MODEL 319 | Tek Marketing, Inc. | 2000-08-30 |
| K001321 | ALL-PRO 2010 | All-Pro Imaging Corp. | 2000-05-16 |
| K992818 | OPTIMAX/ COMPACT 2 | Protec GmbH & Co. KG | 1999-09-01 |
| K990969 | KONICA SRX- 701 AUTOMATIC X-RAY FILM PROCESSOR | Konica Medical Corp. | 1999-06-18 |
| K991435 | AII-PRO 100 PLUS AND ALL-PRO 200 | All-Pro Imaging Corp. | 1999-05-20 |
| K981280 | CP 1000, CURIX HT 330, CLASSIC E.O.S., CURIX HT 530, MAMORAY HT 300, MAMORAY CMPACT PLUS, CURIX COMPACT PLUS, CURIX COMS | Bayer Corp., Agfa Div. | 1998-04-30 |
| K973125 | MAMMOLOADER BY C.M.A. SRL | C.M.A. | 1997-10-08 |
| K970059 | KODAK MINILOADER(2000) | Eastman Kodak Company | 1997-01-27 |
| K962750 | 3M TRIMATIC MODULAR ADVANCED PROCESSING SYSTEM AND 3M APS AUTOMATIC FILM PROCESSOR | Imation Corp. | 1996-08-21 |
| K955706 | JPI AUTOMATIC X-RAY FILM PROCESSOR | Jpi Healthcare Co, Ltd. | 1996-02-12 |
| K951373 | FUJI COMPUTED RADIOGRAPHY SYSTEM FCR9000HQ, FCR9501HQ | Fujifilm Medical System U.S.A., Inc. | 1995-10-27 |
| K954484 | KODAK AUTOMIXER II PLUS | Eastman Kodak Company | 1995-10-18 |
| K954345 | DOOSAN DSP 3800 AUTOMATIC X-RAY FILM PROCESSOR | Doosan Corp. | 1995-10-18 |
| K951397 | KODAK X-OMAT 5000 RA PROCESSOR | Eastman Kodak Company | 1995-05-15 |
| K951396 | KODAK X-OMAT 3000 RA PROCESSOR | Eastman Kodak Company | 1995-05-15 |
| K944046 | FUJI COMPUTED RADIOGRAPHY SYSTEMS | Fujifilm Medical System U.S.A., Inc. | 1995-05-11 |
| K950043 | JPI AUTOMATIC X-RAY FILM PROCESSOR | Jpi Healthcare Co, Ltd. | 1995-05-10 |
| K940112 | X-RAY FILM PROCESSOR | Fischer Industries, Inc. | 1995-04-11 |
| K950358 | KONICA SRX-201 AUTOMATIC X-RA FILM PROCESSOR | Storch Amini & Munves PC | 1995-03-17 |
| K940540 | VELO ACE | Emix U.S.A., Inc. | 1994-07-18 |
| K940558 | 3M XP-2000 X-RAY FILM PROCESSOR | 3M Company | 1994-03-22 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 05060209580777 | IntraX Film Processor | MEDIVANCE INSTRUMENTS LIMITED | 2022-08-06 |
| 05060209580814 | ExtraXtender Film Processor | MEDIVANCE INSTRUMENTS LIMITED | 2022-08-06 |
| B580IWX0 | Mini Med | AFP MANUFACTURING, INC. | 2019-06-19 |
| 08809413810181 | Automatic Radiographic Film Processor | JPI HEALTHCARE. CO., LTD. | 2017-08-01 |
| 04260502640005 | COMPACT 2 | PROTEC GmbH & Co. KG | 2016-10-28 |
| 04260502640012 | ECOMAX | PROTEC GmbH & Co. KG | 2016-10-28 |
| 04260502640029 | OPTIMAX | PROTEC GmbH & Co. KG | 2016-10-28 |
| 04260502640036 | OPTIMAX 2010 | PROTEC GmbH & Co. KG | 2016-10-28 |
| D678450000 | A/T 2000 XR Intraoral Film Processor | AIR TECHNIQUES, INC. | 2016-09-23 |
| D678450040 | A/T 2000 XR Intraoral Film Processor with Water Recirculation System | AIR TECHNIQUES, INC. | 2016-09-23 |
| D678940000 | Peri-Pro III Intraoral Film Processor | AIR TECHNIQUES, INC. | 2016-09-23 |