1. Agfa Direct Digital Mammography DR Mammo Luc.Verstraeten@agfa.com Agfa DR Mammo

2. Topics Why Digital Mammography Agfa’s DR Mammo Agfa DR Mammo

3. Mammography Despite all medical efforts in women’s health,  Breast cancer remains main cause worry/mortality, “Screening” programs expanding, treatment options improving, techniques expanding, screen film still expanding  Need for breast diagnostic still growing, Despite regular progresses/announcements in genetic, optical, new invasive and non invasive imaging,  X-Ray breast imaging remains state of the art,

4. Digital mammo drivers ? FFDM image quality barrier is gone : although several years later than expected, superior technology now allows digital to be equivalent or superior to analog film, High expectations in diagnostic improvements, Cost of maintaining conventional mammography in “filmless” environment, Why Digital Mammography?

5. Material and technical aspects / benefits : Large dynamic range / Wide exposure latitude Increased patient throughput Image processing Digital archiving and retrieval Tele mammography Potential for new clinical applications DSA – neovascular structure detection Potential for reduced breast compression Dual energy subtraction High energy imaging Tomo-synthesis Clinical benefits for patients Dose reduction potential Why Digital Mammography?

6. Topics Why Digital Mammography Agfa’s DR Mammo Agfa DR Mammo

7. Why go digital with Agfa ? Agfa holds a strong position in mammo film market, Agfa holds a strong position in digital imaging management, Agfa has knowledge in digital imaging processing (Musica / CR experiences),  Agfa best and uniquely positioned to offer transition from Analog to Digital for mammography … Agfa’s Mammography Solution

8. Why go digital with Agfa ? Only company that has build a complete portfolio in film, CR, DR, RIS and PACS, Important customer installed base, film, CR, PACS Focus to setup sales organization in Europe to support all aspects of mammo environment  Agfa best and uniquely positioned to offer transition from Analog to Digital for mammography … Agfa’s Mammography Solution

9. Why go digital with DR Mammography? Early solutions : - modality/film makers offer competing DR Solutions, - players have adapted, improved and stretched technology, Market comes to maturity : - Early adopters are behind, - Segmented market opens, Shared CR for low vol. centers, Dedicated DR for larger/special. activities,  Both solutions needed to cover global market,  Agfa first & only company with solutions for all segments, Agfa’s Mammography Solution

10. Digital Mammography positioning story for customer The needs and conditions of mammography examination vary so much (country, practice, activity, environment) Not one digital mammography solution will cover all needs, Agfa offers a range of solutions for different acquisition, reading and workflow management needs  Different acquisition choices are complementary but all integrated in a global workflow solution, - DR is currently available, - Hardcopy and Softcopy are both available, - PACS/RIS solutions available for projects integrated in adequate workflow Agfa’s Mammography Solution

11. DR Mammo Agfa’s Full Field Digital Mammography Solutions

12. Technology - Digital Mammography Topics Agfa DR Mammo Coperation with 3rd party  -Se Detector DM1000 Gantry Acquisition Workstation MUSICA Image Processing Agfa’s Mammo Workstation MA3000

13. Co-operation with 3rd party Agfa enters dedicated DR Mammo with : - best detector technology - proven Mammo equipment - reliable configuration - with a strong partner

14. Technology - Digital Mammography Topics Agfa DR Mammo Coperation with 3rd party  -Se Detector DM1000 Gantry Acquisition Workstation MUSICA Image Processing Agfa’s Mammo Workstation MA3000

15. Digital Image Receptor Direct conversion  -Se Flat Panel -> Direct conversion not affected by light scatter, -> High intrinsic spatial resolution of  -Se, -> 70 microns resolution – 7 lp/mm -> High image quality parameters at maximum resolution, 20% DQE - 50% MTF, -> Compact ‘box’-size versus CCD, Full 24x29 cm field of view -> Accommodates almost all sizes of breast, -> Automatic collimation according to compression paddle  -Se Detector

16. a-Selenium Semiconductor TFT array ---+++---+++ Direct Digital Film X-ray photon Cs-I Scintillator Film TFT array or CCD GE, Fischer Indirect Digital X-ray photon --- Line spread functions --- Phosphor Direct vs Indirect Conversion  -Se Detector

17.  An x-ray photon creates an electron-hole pair in Selenium  A bias voltage drives the holes that are above a pixel electrode into the pixel to be collected  The bias is applied between the top and the bottom of the detector Dr. Martin Yaffe, Imaging Research Program, Sunnybrook and Women's College Health Sciences Centre, Toronto, Canada  -Se Detector

18.  -Se direct capture means... No phosphor No scintillator-layer No intermediate step - direct conversion from X-Ray to electronic signal No light to diffuse or scatter Nothing to degrade the quality of the digital signal  -Se Detector

19. Screen-film Indirect Digital GE Senographe 2000D Direct Digital DM1000 Spatial Frequency (lp/mm)  -Se Detector Data from PMA-FDA submissions Modular Transfer Function (MTF)

20. Direct Digital  -Se Indirect Digital GE Senographe 2000D Screen-film Data from PMA-FDA submissions  -Se Detector Detective Quantum Efficiency (DQE)

21. FFDM Comparison - Detective Quantum Efficiency (DQE)  -Se Detector

22. DQE Selenium in the 20-30 kV range is > 90% efficient Cs-I in the 25-30 kV range is 40% efficient Higher DQE = More efficient use of dose to create an image Less dose needed to create the “same” image, Better image at equivalent dose, Dose reduction?...potentially yes.  -Se Detector

23. ACR Mammography Test Phantom  -Se Detector ACR Phantom Score

24. Technology - Digital Mammography Topics Agfa DR Mammo Coperation with 3rd party  -Se Detector DM1000 Gantry Acquisition Workstation MUSICA Image Processing Agfa’s Mammo Workstation MA3000

25. Mammography gantry build around imaging components selected for optimum image quality : -> Dedicated, bi-angular tube with 0.3 and 0.1mm focal spots, -> EST grid : bi-directional scatter absorption grid for higher contrast improvement, Grid retracts automatically for magnification or special views, -> Molybdenum / rhodium filters manual or automatic selection, DM1000 Gantry

26. DM 1000 components : ->  -Selenium direct conversion detector, -> automated and ergonomic mammography system -> powerful use operator friendly acquisition station, DM1000 Gantry

27. Automation and ergonomics for patient comfort and operator ease of use : -> Motorized C arm with memory / display of positioning, -> Multiple / intelligent compression modes, -> FAST (fully adjustable self tilting) paddle optimizes compression, -> Automatic detection, collimation and exposure adjustments according to paddle choice, -> Multi function foot pedals for “hands free” positioning, -> AEC : available for future commercial units, SW upgrade on installed base DM1000 Gantry

28. Powerful and integration capabilities > Stand alone platform, > Robust Unix platform, > Software developed specifically for digital  -Se flat panel detector control and user interface, > Multi vendor DICOM connectivity compatibility, DM1000 Gantry

29. Technology - Digital Mammography Topics Agfa DR Mammo Coperation with 3rd party  -Se Detector DM1000 Gantry Acquisition Workstation MUSICA Image Processing Agfa’s Mammo Workstation MA3000

30. User friendly and efficient image acquisition station > Logical Graphical User interface > HIS/RIS/barcode/manual patient entry work list selection > Examination sequence automatic or manual management tools > Manual or automatic exposure settings Acquisition Workstation

31. User friendly and efficient image acquisition station > QC functionalities (preview, W/L, magnification) for Immediate image acceptance of image, > Management of rejected images, > 1200 Images local storage Acquisition Workstation

32. Technology - Digital Mammography Topics Agfa DR Mammo Coperation with 3rd party  -Se Detector DM1000 Gantry Acquisition Workstation MUSICA Image Processing Agfa’s Mammo Workstation MA3000

33. MUSICA Multi Scale Image Contrast Amplification MUSICA breaks down digital image in a great number of different frequency ranges (detail sizes) and modulates signal amplitudes (contrast) within each range. MUSICA works on the wide dynamic range of digital mammography images to enhance contrast where necessary. Agfa DR MUSICA Image Processing

34. MUSICA processes images automatically, in real time and background, and remains independent from acquisition or reviewing stations and resources, Retrieving exposure values and raw image information, MUSICA algorithm fetches parameters set for : - Detail contrast and Edge contrast enhancements, - Latitude and noise reductions, MUSICA optimizes hardcopy and softcopy images and increases diagnostic reliability, MUSICA is flexible and user configurable and can be tuned to meet individual radiologist requirements, Agfa DR MUSICA Image Processing

35. · DM1000 Digital Mammography · MUSICA Image Processing · MA3000 Agfa Mammography Workstation · DRYSTAR 4500M Hard Copy · IMPAX - PACS · RIS · Professional Services

36. Agfa DR Mammo Solution CE-marked DM1000 – DRYSTAR 4500M CE, FDA approved DRYSTAR4500M CE, FDA approved Agfa DR Mammo Regulatory Status

37. Installed base DR Mammo 9 Installed systems 6 Planned As of July 15th 2004

38. Agfa Direct Digital Mammography DR Mammo Agfa DR Mammo