Search Results

The AeroDR SYSTEM with P-31 is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in general-purpose diagnostic procedures. The AeroDR SYSTEM with P-31 is not indicated for use in mammography, fluoroscopy, tomography and angiography applications.

The AeroDR SYSTEM with P31(K130936) is a digital imaging system to be used with diagnostic x-ray systems. It consists of AeroDR Detector, Console CS-7 (operator console). Images captured with the flat panel digital detector can be communicated to the operator console via wired connection or wireless, depend on user's choice. The following modifications were added to the AeroDR SYSTEM (K102349/ the predicate device) for the AeroDR SYSTEM with P-31(K130936/ the proposed device). The panel size of 10 x 12 inches (P-31) is added to 14 x 17 inches. The materials of the proposed panel also had been evaluated with the latest ISO 10993-1, and had been assured the safety as same as the predicate device. Two accessories were added: one is AeroDR Interface Unit2 designed to be able to replacement and function of both AeroDR Interface Unit and AeroDR Generator Interface Unit. The other is AeroDR Battery Charger2 designed for the 10X12 inches proposed panel (P-31) which can function as same as the AeroDR Battery Charger of predicate device. Irrespective of those minor modifications, the AeroDR SYSTEM (102349) and AeroDR SYSTEM with P-31(K130936) perform same, and also device design, material used and physical properties of both devices are substantially equivalent.

AeroPilot is a software device that is used in conjunction with REGIUS Unitea to control Konica Minolta Digital Radiography systems. This device is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/ screen systems in general-purpose diagnostic procedures. This device is not indicated for use in mammography, fluoroscopy, tomography and angiography applications.

The AeroPilot is a software device that is used in conjunction with our REGIUS Unitea. K071436, to control Konica Minolta Digital Radiography systems. The AeroPilot is the software designed to be installed in Off-the-shelf PC (operation console) which is one of component of REGIUS Unitea and works with Konica Minolta Digital Radiography systems to be an interface with X-ray generator or between REGIUS Unitea and the specified Konica Minolta Digital Radiography systems, and to acquire X-ray images like the specified Konica Minolta Digital Radiography systems do.

The AeroDR Stitching System is used with Konica Minolta AeroDR SYSTEM which is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in general-purpose diagnostic procedures. This device is used for examinations of long areas of anatomy such as the leg and spine. This device is not indicated for use in mammography, fluoroscopy, tomography and angiography applications.

The AeroDR Stitching System is used with 510(k) cleared Konica Minolta AeroDR SYSTEM (K102349) which is indicated for use in generating radiographic images of human anatomy. The AeroDR Stitching System is an accessory of stationary X-ray system which extends the capability of the AeroDR SYSTEM to allow the capture of long length images with an image area up to 1196mm x 349mm. It consists of AeroDR Stitching Unit, AeroDR Stitching X-ray Auto Barrier Unit and Power Supply Unit. The AeroDR Detecter (K102349) loaded in the AeroDR Stitching Unit takes up to 3 images and transfer them to the Console CS-7 (K102349). Combining the transferred images in the CS-7 enables diagnosis of long images.

AeroDR X70 is a stationary x-ray system intended for obtaining radiographic images of various portions of the human body in a clinical environment. The AeroDR X70 is not intended for mammography

The AeroDR X70 is a stationary x-ray system with a ceiling mounted tube support, a floor mounted table and wall stand. The image receptor and the image receptor holder is placed in the table or the wall stand. The ceiling stand and the table are motorized for up and down movements, all other movements are manually operated. The standard equipment includes a graphic display showing X-ray tube rotation and film focus or source image distance, a generator control console and an Image system console.

The AeroSync for AeroDR SYSTEM is a software device that is used in conjunction with AeroDR SYSTEM. This device is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in general-purpose diagnostic procedures. This device is not indicated for use in mammography, fluoroscopy, tomography and angiography applications.

The AeroSync for AeroDR SYSTEM is a software device that is used in conjunction with our AeroDR SYSTEM, K102349. It adds minor change for our cleared AeroDR SYSTEM. It eliminates the need for an electrical connection between the AeroDR SYSTEM and X-ray generator. It can be detected X-ray irradiation without cables connected to X-ray generator.

The Direct Digitizer, REGIUS SIGMA2 is an X-ray image reader which uses a stimulable phosphor plate (Plate) as X-ray detector installed in a separate cassette. It reads the image recorded on the Plate and transfers the image data to an externally connected device such as a host computer, an order input device, an image display device, a printer, an image data filing device, and other image reproduction devices. It is designed and intended to be used by trained medical personnel in a clinic, a radiology department in a hospital and in other medical facilities. This device is not intended for use in mammography.

The Direct Digitizer, REGIUS SIGMA2 is a compact X-ray image reader which uses a stimulable phosphor plate (Plate) as X-ray detector installed in a cassette, and reads the image recorded on the Plate by inserting a cassette in the entrance slot of this device. By means of laser scan and photoelectric method, this device reads the X-ray image data created in form of a latent image on the Plate exposed by an external X-ray generating device, and converts the read data into digital. The device is comprised of a reading unit with cassette containing Plate. Plates and cassette remain unchanged from the predicate device, REGIUS SIGMA. The image data transfer to an externally connected device such as a host computer, an order input device, an image display device, a printer, an image data filing device, and other image reproduction devices. The basic operations of REGIUS SIGMA2 and the predicate device, REGIUS SIGMA, such as a starting, a shut down, a registration-of-patient, a setting of a various condition are operated with the Medical Image Processing Workstation, ImagePilot (operator console) which is cleared 510(k), K071436. The modification was made from the REGIUS SIGMA to the REGIUS SIGMA2 to increase processing capacity. To increase the processing capacity, the firmware (device mechanical control software) of the reading unit is modified. The outline is as follows. The processing capacity is increased by controlling the feed sequence. (1) Increasing the speed of removal of Plate from cassette and the sequence of storage into cassette (2) Increasing the erasing speed by changing the erasing LED The feed sequence related to Image Quality (Reading speed, Open/Close timing of sub-scanning nip) is not changed.

The AeroDR SYSTEM with P-21 is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in general-purpose diagnostic procedures. The AeroDR SYSTEM with P-21 is not indicated for use in mammography, fluoroscopy, tomography and angiography applications.

The AeroDR SYSTEM, K102349 is a digital imaging system to be used with diagnostic x-ray systems. It consists of AeroDR Defector (flat panel digital detector), Console CS-7 (operator console), AeroDR Interface Unit, AeroDR Generator Interface Unit, AeroDR Access Point and AeroDR Battery Charger. Images captured with the flat panel digital detector can be communicated to the operator console via wired connection or wireless, depend on user's choice. The modification was made to the AeroDR SYSTEM with P-21 to add the different panel size. The panel size of 17 x 17 inches (P-21) is added to 17 x 14 inches. The materials of the panel remain unchanged and no other changes were made other than the panel size from 17 x 14 inches to 17 x 17 inches.

The Konica Minolta Xpress Digital Mammography System is a software device that is used in conjunction with a specified Konica computed radiography system, REGIUS Model 190 or REGIUS Model 210 with REGIUS Cassette Plate CP1M200 and the REGIUS Console CS-3000, and a mammography x-ray unit, to produce full field digital mammography images. The Xpress Digital Mammography software with a specified Konica Minolta computed radiography system is designed to replace screen-film based systems for the production of mammographic images. The device is intended to be used for screening and diagnosis of breast cancer. The mammographic images can be interpreted by a qualified physician using either hard copy film or soft copy display at a workstation.

Konica Minolta's Xpress Digital Mammography is a software device that is used in conjunction with currently marketed Konica computed radiography systems to acquire Full Field Digital Mammography Images. Digital mammography can be performed with the specified Konica Minolta computed radiography systems including the activated Xpress Digital Mammography software using any mammography x-ray unit legally marketed in the U.S .. Konica Minolta does not specify a mammography x-ray unit for use with the specified Konica Minolta computed radiography system with the activated Xpress Digital Mammography software. The components of the specified Konica Minolta computed radiography systems for digital mammography include either REGIUS Models 190 (K052095) or 210 (K092717) Direct Digitizers and the REGIUS Console CS-3000 medical image processing workstation (K051523) with optional bar code reader accessories. The x-ray images produced by the legally marketed x=ray unit:are captured on a REGIUS image plate and digitized using either REGIUS Model 190 or 210 Direct. Digitized images are imported into the REGIUS Console CS-3000 workstation. The REGIUS Console CS-3000 is identical to the REGIUS Console CS-3000 described in K051523, with the Xpress Digital Manimography software activated. The Xpress Digital Mammography software prov a high resolution reading capability and display options specific to the review of mammographic image. Soft. copy images can be transferred to any legally marketed diagnostic viewing station that accepts DICOM 3 input. Hard copy images can be generated using any printer legally marketed for use in digital mammography that supports DICOM basic grayscale print management service with a maximum 50 micrometer pixel pitch and film minimum optical density of at least 3.6.

The Direct Digitizer, REGIUS SIGMA is an X-ray image reader which uses a stimulable phosphor plate (Plate) as X-ray detector installed in a separate cassette. It reads the image recorded on the Plate and transfers the image data to an externally connected device such as a host computer, an order input device, an image display device, a printer, an image data filing device, and other image reproduction devices. It is designed and intended to be used by trained medical personnel in a clinic, a radiology department in a hospital and in other medical facilities. This device is not intended for use in mammography.

The Direct Digitizer, REGIUS SIGMA is a compact X-ray image reader which uses a stimulable phosphor plate (Plate) as X-ray detector installed in a cassette, and reads the image recorded on the Plate by inserting a cassette in the entrance slot of this device. By means of laser scan and photoelectric method, this device reads the X-ray image data created in form of a latent image on the Plate exposed by an external X-ray generating device, and converts the read data into digital. The device is comprised of a reading unit with cassette containing Plate. The image data transfer to an externally connected device such as a host computer, an order input device, an image display device, a printer, an image data filing device, and other image reproduction devices. The basic operations of REGIUS SIGMA such as a starting, a shut down, a registration-of-patient, a setting of a various condition are operated with the Medical Image Processing Workstation, ImagePilot (operator console) which is cleared 510(k), K071436.

The Acies is a software product. It is intended for installation on an off-the-shelf PC meeting or exceeding minimum specifications. The Acies primarily facilitates processing and presentation of medical images on display monitors suitable for the medical task being performed. The Acies can process and display medical images from a variety of different modality systems. It also interfaces to various image storage and printing devices using DICOM or similar interface standards. Lossy compressed mammographic images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 MP resolution and meets other technical specifications reviewed and accepted by FDA.

The Acies is the software that is intended to configure PACS ( Picture Archiving and Communications System ) using a normal Windows-based PC. The workstation on which this software is installed can be utilized as the server-client front-end PC with the function of the Image server and the Viewer to read the image stored in the server. In addition, it is capable to read the image from the client PC through the network. The Acies primarily facilitates processing and presentation of medical images on display monitors suitable for the medical task being performed. The Acies can process and display medical images from a variety of different modality systems. It also interfaces to various image storage and printing devices using DICOM or DICOM based interface standards. Lossy compressed mammographic images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 MP resolution and meets other technical specifications reviewed and accepted by FDA. The system is also capable of displaying the diagnostic image on the display screen by receiving DICOM SR from FDA approved CAD (Computed Aided Detection) processor.