Company ยท US
Eastman Kodak Company
FDA 510(k) clearances and medical device recalls filed under this name, 1977 to 2006. Name variants (Inc, Corp, punctuation) are merged.
238510(k) clearances (0 in 12 months)
3recalls (0 in 12 months)
3recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| IXW | Processor, Radiographic-Film, Automatic | 31 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 18 |
| IWZ | Film, Radiographic | 17 |
| LMC | Camera, Multi Format, Radiological | 14 |
| IXA | Cassette, Radiographic Film | 13 |
| LLZ | System, Image Processing, Radiological | 13 |
| EAM | Screen, Intensifying, Radiographic | 7 |
| LMD | System, Digital Image Communications, Radiological | 7 |
| JAC | System, X-Ray, Film Marking, Radiographic | 6 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 6 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 6 |
| KPR | System, X-Ray, Stationary | 5 |
| LJC | Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group) | 4 |
| LMB | Device, Digital Image Storage, Radiological | 4 |
| MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) | 4 |
| CIG | Diazo Colorimetry, Bilirubin | 3 |
| LMA | Digitizer, Image, Radiological | 3 |
| CEC | Radioimmunoassay, Free Thyroxine | 2 |
| CEK | Biuret (Colorimetric), Total Protein | 2 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 2 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 31, 2006 | K060550 | KODAK DIRECTVIEW DR 3000 SYSTEM 64KW/80KW GENERATORS, MODELS 6551345, 6551386 Eastman Kodak Company | KPR |
| Mar 16, 2006 | K060137 | KODAK ECLIPSE IMAGE PROCESSING SOFTWARE Eastman Kodak Company | MQB |
| Feb 8, 2006 | K060079 | KODAK MODEL CR-7400 DIGITAL RADIOGRAPHY SYSTEM Eastman Kodak Company | MUH |
| Feb 7, 2006 | K060055 | KODAK PACS Eastman Kodak Company | LLZ |
| Jan 4, 2006 | K053347 | KODAK CARESTREAM PACS Eastman Kodak Company | LLZ |
| Jun 21, 2005 | K051483 | KODAK DIRECTVIEW DR SYSTEM DETECTOR Eastman Kodak Company | MQB |
| Jun 1, 2005 | K051258 | KODAK DIRECTVIEW DR 7500 SYSTEM, MODEL 8791345 Eastman Kodak Company | KPR |
| Sep 24, 2004 | K042159 | KODAK COLOR MEDICAL IMAGER 1000 Eastman Kodak Company | LMC |
| Sep 24, 2004 | K042158 | KODAK MEDICAL IMAGER 300 Eastman Kodak Company | LMC |
| May 24, 2004 | K040378 | KODAK DIRECTVIEW CR CASSETTE/GP/15 X 30 CM, CATALOG# 8418253 Eastman Kodak Company | IXA |
| Apr 7, 2004 | K040556 | TROPHYPAN C WITH ORTHOIMAGING/OMSIMAGING ACCESSORY Eastman Kodak Company | EHD |
| Feb 20, 2004 | K033821 | KODAK DRYVIEW 8900 LASER IMAGER MAMMOGRAPHY ACCESSORY Eastman Kodak Company | LMC |
| Nov 26, 2003 | K031132 | CONSULTIVA CASE INPUT STATION, MODEL CIS-1 Eastman Kodak Company | LLZ |
| May 29, 2003 | K030781 | KODAK DIRECTVIEW PACS/IMAGE MANAGEMENT SYSTEM, KODAK DIRECTVIEW WORKFLOW MANAGER,KODAK DIRECTVIEW CX/DX, KODAK DIRECTVIB Eastman Kodak Company | LLZ |
| Jul 10, 2002 | K021903 | KODAK X-OMAT CASSETTE/LEADLESS FOR DENTAL USE Eastman Kodak Company | IXA |
| Jul 2, 2002 | K021829 | MODIFICATION TO KODAK DIRECTVIEW CR 800/900 SYSTEM Eastman Kodak Company | MQB |
| Mar 21, 2002 | K020635 | KODAK DIRECTVIEW CR 800 SYSTEM, CATALOG# 1268622; KODAK DIRECTVIEW CR 900 SYSTEM, CATALOG# 1170976 Eastman Kodak Company | MQB |
| Dec 7, 2001 | K013686 | KODAK DIRECTVIEW TABLETOP CASSETTE Eastman Kodak Company | IXA |
| Aug 10, 2001 | K012155 | KODAK RADIATION ONCOLOGY SOFTWARE/ FOR ACR SYSTEMS Eastman Kodak Company | LLZ |
| Sep 27, 2000 | K002146 | KODAK DRYVIEW 8610 LASER IMAGER / FOR MAMMOGRAPHY Eastman Kodak Company | LMC |
| Feb 11, 2000 | K983928 | KODAK HOME HEALTH MONITORING SYSTEM Eastman Kodak Company | MWI |
| Jan 25, 1999 | K983905 | KODAK DIGITAL SCIENCE 3600 DISTRIBUTED MEDICAL IMAGER, KODAK DIGITAL SCIENCE 1200 DISTRIBUTED MEDICAL IMAGER, MODEL 3600 Eastman Kodak Company | LMC |
| Jul 17, 1998 | K973430 | KODAK PRO-MEDICAL DIGITAL CAMERA SYSTEM Eastman Kodak Company | GCJ |
| Jun 18, 1998 | K981053 | KODAK DIGITAL SCIENCES (KDS) IMAGE VIEW Eastman Kodak Company | LMD |
| Mar 17, 1998 | K980118 | KODAK DIGITAL SCIENCE ONCOLOGY IMAGE MANAGER Eastman Kodak Company | LLZ |
| Jan 21, 1998 | K974107 | KODAK DIGITAL SCIENCE QUALITY CONTROL WORKSTATION (QCW) Eastman Kodak Company | LMD |
| Jan 20, 1998 | K974086 | KODAK DIGITAL SCIENCE CARDIAC VIEWER Eastman Kodak Company | LLZ |
| Nov 10, 1997 | K973476 | KODAK DIGITAL SCIENCE-DENTAL IMAGE VIEWER Eastman Kodak Company | EHD |
| Oct 7, 1997 | K972847 | KODAK DIGITAL SCIENCE 9000D MEDICAL LASER PRINTER (9000D) Eastman Kodak Company | LMC |
| Sep 11, 1997 | K972380 | KODAK DIGITAL SCIENCE (KDS) MEDICAL IMAGE AND INFORMATION LIBRARY (MIIL) Eastman Kodak Company | LMB |
| Aug 25, 1997 | K971973 | KODAK DIGITAL SCIENCE PRO-MEDICAL THERMAL PRINTER Eastman Kodak Company | LLZ |
| Aug 20, 1997 | K971894 | KODAK DIGITAL SCIENCE - DENTAL SCANNING SYSTEM Eastman Kodak Company | LMA |
| Apr 4, 1997 | K970154 | KODAK EKTASIAN HG FILM (EHG-15) Eastman Kodak Company | IWZ |
| Jan 27, 1997 | K970059 | KODAK MINILOADER(2000) Eastman Kodak Company | IXW |
| Sep 20, 1996 | K962896 | KODAK DIGITAL SCIENCE REMOTE CASSETTE Eastman Kodak Company | KPR |
| Jul 25, 1996 | K961453 | KODAK MN-R 2000 CASSETTE Eastman Kodak Company | IXA |
| May 28, 1996 | K960834 | KODAK EC-L CASSETTE Eastman Kodak Company | IYE |
| Apr 17, 1996 | K960382 | KODAK DIGITAL SCIENCE MEDICAL IMAGE MANAGER Eastman Kodak Company | LMD |
| Oct 18, 1995 | K954484 | KODAK AUTOMIXER II PLUS Eastman Kodak Company | IXW |
| May 15, 1995 | K951397 | KODAK X-OMAT 5000 RA PROCESSOR Eastman Kodak Company | IXW |
| May 15, 1995 | K951396 | KODAK X-OMAT 3000 RA PROCESSOR Eastman Kodak Company | IXW |
| Oct 20, 1994 | K942610 | KODAK EXTACHEM CLINICAL CHEMISTRY SLIDE DIGOXIN (DGXN) Eastman Kodak Company | LFM |
| Aug 17, 1994 | K940386 | KODAK AUTOMIXER III INTEGRATED, KODAK AUTOMIXER III 180 LP Eastman Kodak Company | IXL |
| Jul 29, 1994 | K942909 | KODAK INSIGHT TWIN-LOAD INSERT Eastman Kodak Company | EAM |
| Jun 13, 1994 | K941142 | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE PHENYTOIN Eastman Kodak Company | DIP |
| Apr 29, 1994 | K936116 | KODAK EKTASCAN NETWORK INTERFACE/FOR OTHER MANUFACTURERS Eastman Kodak Company | LMD |
| Apr 25, 1994 | K934413 | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ASPARATE AMIMOTRANSFERASE Eastman Kodak Company | CIT |
| Apr 25, 1994 | K934106 | KODAK EKTACHEM DTSC II SLIDES (LI) Eastman Kodak Company | JIH |
| Apr 25, 1994 | K932728 | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (URIC) Eastman Kodak Company | KNK |
| Apr 8, 1994 | K936287 | KODAK SURECELL HCG URINE TEST, MODIFICATION Eastman Kodak Company | JHI |
Newest 50 of 238.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 8, 2005 | Eastman Kodak Co KODAK DirectView DR 7100 System, Catalog # 133-6049. This is a digital radiology system. The major components are: operator console; digital imaging capture device; tilting table with floating top; Terminated |
KPR | K001341 |
| May 11, 2005 | Eastman Kodak Co KODAK GP FLEXIBLE PHOSPHOR SCREENS, for use with Kodak DirectView CR 500 systems. Responsible firm on label: Made in U.S.A. by Eastman Kodak Company, Rochester, N.Y. 14650. Screens are sold in the Terminated |
IXJ | K925997 |
| Jul 20, 2004 | Eastman Kodak Co Kodak DirectView DR 7100 System, Catalog #133-6049, a digital radiology system. The major system components are: operator console; digital imaging capture device; tilting table with floating top; ce Terminated |
KPR | K001341 |