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The ergo Imaging System is intended to image the distribution of radionuclides in the body by means of a photon radiation detector. In so doing, the system produces images depicting the anatomical distribution of radioisotopes within the human body for interpretation by authorized medical personnel. The ergo Imaging System is used by trained medical personnel to perform nuclear medicine studies. It is indicated for lymphatic scintigraphy and parathyroid scintigraphy, It can be used intraoperatively when protected by sterile drapes. It is also indicated to aid in the evaluation of lesions in the breast and other small body parts. When used for breast imaging, it is indicated to serve as an adjunct to mammography or other primary breast imaging modalities.

The ergo Imaging System incorporates Digirad's Solid State RIM detector design with 3mm pixels for general purpose planar imaging, cleared under K100838. Sterile drapes are specified for intraoperative use. The ergo Imaging System, in conjunction with the optional Breast Imaging Accessory (BIA), enables the user to perform scintimammography and extremity imaging with stabilization.

The ergo Imaging System is intended to image the distribution of radionuclides in the body by means of a photon radiation detector. In so doing, the system produces images depicting the anatomical distribution of radioisotopes within the human body for interpretation by authorized medical personnel.

The proposed changes involve modifications to the 2020tc Imaging System to increase size of the detector head field of view (FOV) from 8"x 8" to 12"x 15". Modifications include mechanical and electrical design changes to support the large field-of-view (LFOV) detector head. The modified device (ergo Imaging System) incorporates Digirad's solid-state RIM detector design, modified with 3mm size pixels required for general purpose planar imaging. The 2020tc Imager detectors currently utilize the same 3mm pixel size. The detectors used in the modified and predicate device utilize a pixelated, multi-crystal CsI scintillator detector with each pixel optically coupled to a low noise photodiode array. The charge detected from each gamma ray is amplified and processed using an amplifier circuit. The RIM detector design technology is currently used in the Digirad Cardius XPO imager systems with a 6mm pixel size for Cardiac SPECT imaging. The RIM detector has been modified to incorporate a 3mm size pixel required for general planar imaging. The RIM detector design includes electrical and mechanical configurations allowing for field replacement of detector modules and improved system performance (better energy resolution). The updated design of the RIM detector head assembly allows some of the current sub-systems to be moved into the detector head assembly (air dryer) and simplification of others (cooling and power distribution systems). The modified device uses the 2020tc Imaging System SeeQuanta Acquisition software, with minor modifications required for use with the 3mm pixel size RIM detector modules. The 2020tc Imager was initially marketed as the Digirad Notebook Imager (K961104), then re-branded as the 2020tc Imaging System (K982855) when it was used in conjunction, with the SPECTour Rotating Chair to obtain SPECT images in patients who are seated in an upright position. The modified device (ergo Imaging System) is a general purpose Nuclear Medicine Imaging device used for planar imaging, the same as the Notebook Imager/20201c Imager when imaging without the rotating chair.

The Cardius 3 X-ACT Imaging System is a gamma camera for Single Photon Emission Computed Tomography (SPECT) integrated with an attenuation device consisting of an x-ray generator. The Cardius 3 X-ACT Imaging System is intended for use in the generation of cardiac studies, including planar and SPBCT studies, in nuclear medicine applications. Cardius 3 X-ACT produces non-attenuation corrected SPECT Images and attenuation corrected SPECT images with x-ray transmission data that may also be corrected for scatter.

The Cardius® 3 X-ACT Imaging system is a gamma camera for the acquisition and processing of Single Photon Emission Computed Tomography (SPECT) as well as correcting attenuation artifacts associated with these Emission studies. The device consists of an x-ray generator integrated with the previously cleared Cardius 3 XPO triple head SPECT system to provide attenuation correction functionality. The attenuation correction functionality will be included with the Cardius 3 X-ACT imaging system, or offered as an accessory for previously purchased Cardius 3 XPO systems that are configured to accept the attenuation correction functionality. The Cardius 3 X-ACT Imaging system is designed to provide extended imaging functionality relative to the current Cardius XPO series imagers. A typical patient study comprises an emission (SPECT) study followed by a transmission study. The SPECT study is acquired using the similar system hardware and software technology as a Cardius-3 XPO imaging system. For the transmission study, the low dose x-ray generator is used to produce an attenuation map that is used for attenuation correction (AC) of the emission data. An iterative reconstruction technique then uses the attenuation map and the SPECT data as input, and the AC and non-AC reconstructed volumes are saved in the database for physician review. The attenuation correction data provided is additional information that may be reviewed by the interpreter. The original SPECT data remains available to the interpreter.

The STASYS Motion Correction software program is intended for use in correcting patient motion artifacts in SPECT data acquired on a nuclear medicine gamma camera system.

STASYS™ is a software application developed by Digirad for the correction of SPECT acquisition motion artifacts from gated and non-gated projection datasets. When the program is activated, STASYS uses algorithms developed by Digirad to minimize motion error metrics over the set of acquired projections. The resulting STASYS corrected projections are presented to the operator for acceptance or rejection of the correction. With STASYS software, cardiac SPECT studies acquired with both parallel hole and non-parallel hole collimators, can be motion corrected. The STASYS software has the same indications for use and function as the Cedars-Sinai designed MoCo software, currently being used on Digirad SPECT imaging systems and processing workstations.

Cardius-1, Cardius-2, Cardius-3, Cardius 1 XPO, Cardius 3 XPO, Cardius 3 XPO Imaging Systems: The Cardius product models are intended for use in the generation of cardiac studies, including planar and Single Photon Emission Computed Tomography (SPECT) studies, in nuclear medicine applications. 2020tc SPECT Imaging System: The Digirad 2020tc SPECT Imaging system is intended for use in the generation of both planar and Single Photon Emission Computed Tomography (SPECT) clinical images in nuclear medicine applications. The Digirad SPECT Rotating Chair is used in conjunction with the Digirad 2020tc Imager™ to obtain SPECT images in patients who are seated in an upright position. Specifically, the 2020tc Imager™ is intended to image the distribution of radionuclides in the body by means of a photon radiation detector. In so doing, the system produces images depicting the anatomical distribution of radioisotopes within the human body for interpretation by authorized medical personnel.

The proposed change involves an updated version of nSPEED™ (3D-OSEM) reconstruction software to process cardiac SPECT studies acquired with non-parallel hole collimators, using half time and/or half count densities. With the updated software, cardiac SPECT studies acquired with both parallel hole and non-parallel hole collimators, using half time and/or half count densities, can be processed.

Cardius 1 XPO, Cardius 2 XPO, Cardius 3 XPO Imaging Systems: The Cardius product models are intended for use in the generation of cardiac studies, including planar and Single Photon Emission Computed Tomography (SPECT) studies. in nuclear medicine applications. 2020tc SPECT Imaging System: The Digirad 2020tc SPECT Imaging system is intended for use in the generation of both planar and Single Photon Emission Computed Tomography (SPECT) clinical images in nuclear medicine applications. The Digirad SPECT Rotating Chair is used in conjunction with the Digirad 2020tc Imager™ to obtain SPECT images in patients who are seated in an upright position. Specifically, the 2020tc Imager™ is intended to image the distribution of radionuclides in the body by means of a photon radiation detector. In so doing, the system produces images depicting the anatomical distribution of radioisotopes within the human body for interpretation by authorized medical personnel.

Mirage XP is an automated processing and interpretation software package. This software will be available as standard software on the Digirad imaging systems and/or as a standalone software package on a workstation or a laptop. The enhancements to previous versions of software include automated processing, preference based selections, improved EF algorithm and segment scoring for quantification and interpretation.

Cardius-1, Cardius-2, Cardius-3: The Cardius product models are intended for use in the generation of cardiac studies, including planar and Single Photon Emission Computed Tomography (SPECT) studies, in nuclear medicine applications. 2020tc SPECT Imaging System: The Digirad 2020tc SPECT Imaging system is intended for use in the generation of both planar and Single Photon Emission Computed Tomography (SPECT) clinical images in nuclear medicine applications. The Digirad SPECT Rotating Chair is used in conjunction with the Digirad 2020tc Imager™ to obtain SPECT images in patients who are seated in an upright position. Specifically, the 2020te Imager™ is intended to image the distribution of radionuctides in the body by means of a photon radiation detector. In so doing, the system produces images depicting the anatomical distribution of radioisotopes within the human body for interpretation by authorized medical personnel.

The changes to the Digirad 2020tc and Cardius SPECT imaging cameras involve addition of an Image Stabilization System. The proposed Image Stabilization System is used to correct image studies for patient motion in SPECT data acquired with Digirad Nuclear medicine gamma camera systems. The Image Stabilization System consists of two parts: a Hardware component that mounts to the SPECT Imaging System, and a software module that collects data from the hardware and corrects the image data for motion. The resulting motion corrected patient study data is referred to as the Image Stabilized Patient Study. The Image Stabilization system may operate only with the above described Digirad Camera models and is compatible with proprietary Digitad Acquisition Software under the Windows Operating system and standard PC architecture. The proposed Image Stabilization System performs substantially the same function as the currently cleared Cedar's Sinai Motion Correction Program (MoCo), cleared for use on Digirad SPECT Imaging Systems under Digirad 510(k) #K023110. The proposed Image Stabilization System automatically produces an Image Stabilized Patient Study, corrected for patient motion, which is available in the existing database. The original image study is produced in an identical manner as in the previously cleared devices. Both studies are stored in the same patient record in the database. Additional minor changes were made to the User Interface screen. The Image Stabilized Patient Studies produced by the proposed device are identical in file structure to the original, unmodified data set; therefore SeeQuanta 1.2 and the Image Stabilization System are fully compatible with the same database, reconstruction software, and processing software that is used with the "cleared" devices. Hence, there are no changes to these software modules. This proposed optional software addition will be available to Digirad customers both integrated with the Digirad 2020tc SPECT Imaging System, and Cardius-1, Cardius-2, and Cardius-3 SPECT Imaging Systems, and separately as a retrofit device for existing Digirad Product Customers.

Cardius-1, Cardius-2, Cardius-3: The Cardius product models are intended for use in the generation of cardiac studies, including planar and Single Photon Emission Computed Tomography (SPECT) studies, in nuclear medicine applications. 2020tc SPE.CT Imaging System: The Digirad 2020tc SPECT Imaging system is intended for use in the generation of both planar and Single Photon Emission Computed Tomography (SPECT) clinical images in nuc ear medicine applications. The Digirad SPECT Rotating Chair is used in conjunction with the Digirad 2020tc Imager™ to obtain SPECT images in patients who are seated in an upright position. Specifically, the 2020te Imager™ is intended to image the distribution of radionuclides in the body by means of a photon radiation detector. In so doing, the system produces images depicting the anatomical distribution of radioisotopes within the human body for interpretation by authorized medical personnel.

The changes to the Cardius and 2020tc cameras involve modifications to the data acquisition software used on the gamma cameras. The primary change to the data acquisition software involves the addition of a Camera Center-of-Rotation (COR) quantitative check. Additional minor changes were made to the User Interface screen. There were no hardware changes to the cameras.

The Cardius product models are intended for use in the generation of cardiac studies, including planar and Single Photon Emission Computed Tomography (SPECT) studies, in nuclear medicine applications.

The Cardius model cameras are gantry (open gantry, upright seated) devices designed for single- (Cardius-1) or dual-detector (Cardius-2) cardiac nuclear imaging studies. The device includes an acquisition/processing station, a gantry, one or two detectors, and a gantrymounted patient imaging chair. The patient imaging chair is mechanized to accommodate patient loading and cardiac centering in the detector field of view. The imaging chair motion control allows for acquisition of Cardiac SPECT and planar studies, including static, dynamic, gated/non-gated SPECT (circular orbit only).

The Cedars-Sinai Motion Correction (MoCo) software program is intended for use in correcting patient motion artifacts in SPECT data acquired on a nuclear medicine gamma camera system.

The MoCo program is an independent, standalone software application developed by Cedars-Sinai Medical Center for the automatic and manual correction of SPECT acquisition motion artifacts from gated and ungated projection datasets. MoCo is the most popular motion correction application in the field of nuclear myocardial perfusion SPECT imaging. The software has the same indication for use and function as the Motion Correction function module of Mirage software (Segami Corporation, K972886), which is currently being used on Digirad 2020tc SPECT Imaging systems.