FDA Product Code
FDA Product Code MQB — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.1680
510(k) Clearances — 424 records · page 4 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K111312 | SANTEVIEW | Sehyun Co., Ltd. | 2011-07-13 | Traditional | PDF ↗ |
| K103703 | REGUIS SIGMA | Konica Minolta Medical & Graphic, Inc. | 2011-06-02 | Traditional | PDF ↗ |
| K102479 | ALARA T210 COMPUTED RADIOGRAPHY SYSTEM | Alara, Inc. | 2011-06-02 | Traditional | PDF ↗ |
| K111098 | INNOVAXION FP, INNOVAXION FP 1600 PLUS, MAGELLAN | Imaging Dynamics Company , Ltd. | 2011-05-27 | Special | PDF ↗ |
| K102619 | COMPUTED RADDIOGRAPHY SCANNER | 3Disc Americas | 2011-05-13 | Traditional | PDF ↗ |
| K103599 | UNIVERSAL DIGITAL INTERFACE (UDI) 1717 | Meridian Medical Systems, LLC | 2011-04-27 | Traditional | PDF ↗ |
| K110210 | SATURN 8000-GS | New Medical Co., Ltd. | 2011-04-20 | Traditional | PDF ↗ |
| K103591 | DIGITAL RADIOGRAPHY | Canon Inc. -Medical Equipment Group | 2011-03-29 | Special | PDF ↗ |
| K103596 | WIRELESS/WIRED FDR D-EVO FLAT PANEL DETECTOR | Fujifilm Medical Systems U.S.A, Inc. | 2011-03-29 | Special | PDF ↗ |
| K102474 | FLAATZ 750E | Drtech Corp. | 2011-03-04 | Traditional | PDF ↗ |
| K102321 | DIGITAL FLAT PANEL X-RAY DETECTOR MODEL SDX-4336CP | Samsung Mobile Display Co., Ltd. | 2011-02-11 | Traditional | PDF ↗ |
| K100703 | STATIONARY X-RAY SYSTEM (DETECTOR) MODEL: ALTAS | Comed Co., Ltd. | 2010-12-21 | Traditional | PDF ↗ |
| K102587 | LLX240AB01 | Samsung Mobile Display Co., Ltd. | 2010-12-01 | Traditional | PDF ↗ |
| K101590 | DIGITAL FLAT PANEL X-RAY DETECTOR | VATECH Co., Ltd. | 2010-11-29 | Traditional | PDF ↗ |
| K102615 | WIRELESS DR IMAGING OPTION-WDR1 | Ge Medical Systems, LLC | 2010-11-18 | Traditional | PDF ↗ |
| K102012 | DIGITAL RADIOGRAPHY | Canon Inc. -Medical Equipment Group | 2010-08-17 | Special | PDF ↗ |
| K091090 | DIGITAL FLAT PANEL X-RAY DETECTOR, MODEL XMARU 1717 | E-Woo Technology | 2010-08-09 | Traditional | PDF ↗ |
| K101289 | SCANX D5000 SERIES SCANNER MODEL: D5000-F, D5000-FB, D5000-FVB, D5000-Q, D5000-QB | Air Techniques, Inc. | 2010-08-03 | Traditional | PDF ↗ |
| K100762 | FLAT PANEL DETECTOR, MODEL FDR D-EVO | Fujifilm Medical Systems U.S.A, Inc. | 2010-07-15 | Traditional | PDF ↗ |
| K100001 | MOBIVISION | Almana Medical Imaging | 2010-06-25 | Traditional | PDF ↗ |
| K093790 | SIMONDR DRP | Simondr, Inc. | 2010-04-05 | Traditional | PDF ↗ |
| K093427 | FDR ACSELERATE SYSTEM, DR-ID 200 FLAT PANEL DETECTOR | Fujifilm Medical System U.S.A., Inc. | 2010-01-21 | Abbreviated | PDF ↗ |
| K092669 | DX-D IMAGING PACKAGE | Agfa Healthcare N.V. | 2009-11-06 | Traditional | PDF ↗ |
| K092717 | DIRECT DIGITIZER, REGIUS MODEL 210 | Konica Minolta Medical & Graphic, Inc. | 2009-10-30 | Special | PDF ↗ |
| K090742 | DIGITAL FLAT PANEL X-RAY DETECTOR, MODEL LTX240AA01-A | Samsung Mobile Display Co., Ltd. | 2009-09-18 | Traditional | PDF ↗ |
| K092238 | AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH DX-G DIGITIZERS | Agfa Healthcare N.V. | 2009-08-11 | Traditional | PDF ↗ |
| K082450 | IDR | Icrco, Inc. | 2009-06-30 | Traditional | PDF ↗ |
| K091545 | DIGITAL RADIOGRAPHY CXDI-60C | Canon, Inc. | 2009-06-15 | Traditional | PDF ↗ |
| K091436 | DIGITAL RADIOGRAPHY, MODEL CXDI-55C | Canon, Inc. | 2009-05-29 | Traditional | PDF ↗ |
| K091435 | DIGITAL RADIOGRAPHY MODEL CXDI-55G | Canon, Inc. | 2009-05-29 | Traditional | PDF ↗ |
| K090062 | WV1417A DIGITAL X-RAY DIRECT IMAGING FLAT PANEL DETECTOR SYSTEM | Direct Digital Imaging Technology (Beijing), Inc. | 2009-05-18 | Traditional | PDF ↗ |
| K090672 | AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX WORKSTATIONS | Agfa Healthcare N.V. | 2009-05-18 | Traditional | PDF ↗ |
| K090318 | CARESTREAM DRX-1 SYSTEM | Carestream Health, Inc. | 2009-04-06 | Traditional | PDF ↗ |
| K090625 | WIRELESS PORTABLE DETECTOR FD-W17 | Philips Medical Systems North America Co. | 2009-03-24 | Traditional | PDF ↗ |
| K090623 | DIGITAL RADIOGRAPHY CXDI-40G COMPACT | Canon USA, Inc. | 2009-03-24 | Traditional | PDF ↗ |
| K083224 | CPI RAD VISION, MODEL VZW2944XX-YY | Communications & Power Industries Canada, Inc. | 2009-03-24 | Traditional | PDF ↗ |
| K083645 | RADSTAR FAMILY, MODELS: RADSTAR 4343 & VARIATIONS | 5 Star Medical, Inc. | 2009-02-24 | Traditional | PDF ↗ |
| K082347 | DIGITAL RADIOGRAPHY, FLEXDR C30 | Konica Minolta Technoproduct Co., Ltd. | 2008-11-18 | Traditional | PDF ↗ |
| K082494 | DRAD3000E/RADREX-I | Toshiba America Medical Systems, In.C | 2008-09-12 | Traditional | PDF ↗ |
| K081963 | AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX2008 WORKSTATIONS | Agfa Healthcare Corporation | 2008-07-25 | Traditional | PDF ↗ |
| K081648 | DIGITAL RADIOGRAPHY CXDI-60G | Canon, Inc. | 2008-06-24 | Traditional | PDF ↗ |
| K081624 | INFX-8000F (INFINIX CSI AND INFINIX DPI) | Toshiba America Medical Systems, In.C | 2008-06-23 | Traditional | PDF ↗ |
| K080589 | SATURN 9000-810 | New Medical Co., Ltd. | 2008-06-11 | Special | PDF ↗ |
| K073670 | KODAK POINT OF CARE CR 120, KODAK POINT OF CARE CR 140, KODAK POINT OF CARE CR 260 | Orex Computed Radiography, Ltd. | 2008-01-25 | Special | PDF ↗ |
| K080064 | FLAATZ 750 | Drtech Corp. | 2008-01-23 | Traditional | PDF ↗ |
| K073165 | DRAD-3000E, RADREX-I | Toshiba America Medical Systems, In.C | 2007-11-16 | Traditional | PDF ↗ |
| K072984 | SATURN 9000-550 | New Medical Co., Ltd. | 2007-11-14 | Special | PDF ↗ |
| K073056 | DIGITAL RADIOGRAPHY SYSTEM, MODEL: QXR-9 | Vieworks Co., Ltd. | 2007-11-13 | Traditional | PDF ↗ |
| K072983 | SATURN 9000-750 | New Medical Co., Ltd. | 2007-11-13 | Special | PDF ↗ |
| K071682 | CRYSTALVIEW T-SERIES COMPUTED RADIOGRAPHY SYSTEM, MODELS T110 (WITH ERASER) AND T100 (WITHOUT ERASER) | Alara, Inc. | 2007-08-15 | Traditional | PDF ↗ |
| K063710 | SATURN 9000 | New Medical Co., Ltd. | 2007-07-16 | Traditional | PDF ↗ |
| K071193 | VIDAR VISION 3000 AND 4000 X-RAY SYSTEMS | Vidar Systems Corp. | 2007-05-30 | Special | PDF ↗ |
| K071181 | DIRECT DIGITIZER, REGIUS MODEL 110 | Konica Minolta Medical & Graphic, Inc. | 2007-05-30 | Special | PDF ↗ |
| K070829 | SYNEPIX 4600 DETECTOR | Analogic Corporation | 2007-05-09 | Abbreviated | PDF ↗ |
| K071162 | AGFA COMPUTED RADIOGRAPHY SYSTEM WITH NX2.X WORKSTATIONS | Agfa Healthcare Corp. | 2007-05-08 | Traditional | PDF ↗ |
| K070563 | VIDAR VISION 2000 | Vidar Systems Corp. | 2007-03-16 | Traditional | PDF ↗ |
| K070528 | PHILIPS ESSENTA DR | Philips Medical Systems GmbH, Dmc | 2007-03-09 | Traditional | PDF ↗ |
| K070079 | X3C DIGITAL RADIOGRAPHIC DETECTOR | Imaging Dynamics Company , Ltd. | 2007-01-31 | Special | PDF ↗ |
| K063421 | DX-SI | Agfa Corp. | 2006-11-22 | Traditional | PDF ↗ |
| K063283 | DEFINIUM 5000 X-RAY SYSTEM | Sedecal., Sa. | 2006-11-17 | Special | PDF ↗ |
| K063039 | XPLORER 2200 DIGITAL RADIOGRAPHIC SYSTEM | Imaging Dynamics Company , Ltd. | 2006-11-02 | Special | PDF ↗ |
| K062376 | DIRECT DIGITAL RADIOGRAPHY CCD IMAGING SENSOR, NAOMI | Rf Systems Lab. | 2006-10-27 | Traditional | PDF ↗ |
| K062742 | CR 85-X | Agfa Corporation | 2006-10-13 | Special | PDF ↗ |
| K062586 | XPLORER 1600 PLUS | Imaging Dynamics Company , Ltd. | 2006-09-29 | Special | PDF ↗ |
| K062390 | CRYSTALVIEW R200 | Alara, Inc. | 2006-09-18 | Special | PDF ↗ |
| K062223 | AGFA MODEL CR30-X | Agfa Corporation | 2006-09-01 | Special | PDF ↗ |
| K062221 | CXDI-40EC | Canon, Inc. | 2006-08-17 | Traditional | PDF ↗ |
| K061538 | ALARA CRYSTALVIEW COMPUTED RADIOGRAPHY SYSTEM, MODEL R200 | Alara, Inc. | 2006-06-30 | Special | PDF ↗ |
| K052661 | QUIX DIGITAL RADIOGRAPHIC UPGRADE | Edge Medical Devices , Ltd. | 2006-06-07 | Traditional | PDF ↗ |
| K061054 | AXIOM ARISTOS FX PLUS | Siemens Medical Solutions USA, Inc. | 2006-05-09 | Special | PDF ↗ |
| K060137 | KODAK ECLIPSE IMAGE PROCESSING SOFTWARE | Eastman Kodak Company | 2006-03-16 | Special | PDF ↗ |
| K060433 | DIGITAL RADIOGRAPHY CXDI-50C | Canon, Inc. | 2006-03-10 | Traditional | PDF ↗ |
| K053634 | COMPUTED RADIOGRAPHY SYSTEM WITH NX 1.0 WORKSTATION | Agfa Corporation | 2006-01-17 | Special | PDF ↗ |
| K053029 | NDR+/DIVA-D | Nical Spa | 2006-01-06 | Abbreviated | PDF ↗ |
| K052938 | CR-PRO | Eradlink, Inc. | 2005-11-17 | Traditional | PDF ↗ |
| K052095 | MODIFICATION TO: DIRECT DIGITIZER REGIUS MODEL 190 | Konica Minolta Medical & Graphic, Inc. | 2005-11-03 | Traditional | PDF ↗ |
| K051998 | REGIUS MODEL 170 DIRECT DIGITIZER | Konica Minolta Medical & Graphic, Inc. | 2005-11-03 | Traditional | PDF ↗ |
| K051494 | MEDICAL IMAGE DIGITIZER, MODELS CDCR 5020S, UCCR7001 AND TCCR 7001 | Cr Tech, Ltd. | 2005-09-21 | Traditional | PDF ↗ |
| K052136 | GR17 DIGITAL DETECTOR | Anrad Corp. | 2005-08-25 | Special | PDF ↗ |
| K051418 | DIRECT DIGITIZER REGIUS MODEL 370 | Konica Minolta Medical & Graphic, Inc. | 2005-07-01 | Special | PDF ↗ |
| K042791 | INSTANT-X, MODELS 1713 & 128 | Ann Arbor Digital Devices | 2005-07-01 | Traditional | PDF ↗ |
| K051483 | KODAK DIRECTVIEW DR SYSTEM DETECTOR | Eastman Kodak Company | 2005-06-21 | Traditional | PDF ↗ |
| K050925 | DIGITAL RADIOGRAPHY SYSTEM RADSPEED SAFIRE | Shimadzu Corp. | 2005-06-01 | Abbreviated | PDF ↗ |
| K050718 | DDRCOMBI TRAUMA | Swissray International, Inc. | 2005-05-26 | Traditional | PDF ↗ |
| K050987 | DIGITAL RADIOGRAPHY MODEL CXDI-40EG | Canon, Inc. | 2005-04-27 | Traditional | PDF ↗ |
| K050810 | AGFA CR50.0 | Agfa Corp. | 2005-04-21 | Special | PDF ↗ |
| K042602 | REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH MANUAL IMAGE PASTING | Ge Medical Systems, LLC | 2005-01-13 | Special | PDF ↗ |
| K042386 | DIRECT DIGITIZER, REGIUS MODEL 190 | Konica Minolta Medical & Graphic, Inc. | 2004-12-15 | Special | PDF ↗ |
| K042821 | DIGITAL DETECTOR, MODEL GR17 | Anrad Corp. | 2004-10-22 | Abbreviated | PDF ↗ |
| K042397 | SCANX 14 | Air Techniques, Inc. | 2004-10-05 | Special | PDF ↗ |
| K042041 | XPLORER 1600 | Imaging Dynamics Company Limited | 2004-09-17 | Traditional | PDF ↗ |
| K042023 | FUJI COMPUTED RADIOGRAPHY (FCR) CLEARVIEW CS IMAGE READER | Fujifilm Medical System U.S.A., Inc. | 2004-08-25 | Traditional | PDF ↗ |
| K041701 | AFGA CR25.0 COMPUTED RADIOGRAPHY SYSTEM | Agfa Corp. | 2004-07-22 | Special | PDF ↗ |
| K033561 | FUJI COMPUTED RADIOGRAPHY (FCR) VELOCITY IMAGE READER | Fujifilm Medical System U.S.A., Inc. | 2003-11-26 | Traditional | PDF ↗ |
| K032210 | ALARA CRYSTALVIEW COMPUTED RADIOGRAPHY SYSTEM | Alara, Inc. | 2003-10-02 | Traditional | PDF ↗ |
| K031198 | SCANX 10 | Air Techniques, Inc. | 2003-06-20 | Traditional | PDF ↗ |
| K031633 | CANON INC., DIGITAL RADIOGRAPHY, MODEL CXDI-40C | Canon USA, Inc. | 2003-06-11 | Traditional | PDF ↗ |
| K031447 | CANON, DIGITAL RADIOGRAPHY, MODEL CXDI-50G | Canon, Inc. | 2003-05-21 | Traditional | PDF ↗ |
| K024147 | PAXSCAN 4030 MEDICAL DIGITAL IMAGING SYSTEM | Varian Medical Systems, Inc. | 2003-02-12 | Traditional | PDF ↗ |
| K023750 | CANNON DIGITAL RADIOGRAPHY MODEL CXDI-40G | Canon USA, Inc. | 2002-11-22 | Traditional | PDF ↗ |
Product code MQB · Class II · Radiology. Data: openFDA.