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The 1-650 Mammography System is intended to produce radiographic images of the breast. Its specific intended use is for screening and diagnostic mammography. Screening mammography involves the production of images for initial examination for breast cancer diagnosis. Diagnostic mammography includes the production of magnified images for more thorough examination of areas of the breast determined suspicious through screening mammography, special views, spot compression views, and the production of images used by a physician in preparation for biopsy.

The Lorad I-650 mammography system is based on Lorad's currently marketed D-550 (K934870) and Elite (K973631) Dedicated Mammographic Systems. The mechanical packaging is similar to the D-550, while the electronics are similar to the Elite. The Lorad I-650 is a standalone mammography device, mounted on a base to be permanently mounted in position. The unit is AC powered, and must be connected to a 220 VAC/50-60 Hertz (nominal) line to operate. The standalone unit has two major assemblies: The C-arm and the Gantry. The C-arm, which contains the x-ray tube, an image receptor support, compression device, a beam limiting device, switches that actuate the C-arm functions, and sensors for detecting installed accessories and making radiation measurements, is attached to the front (patient side) of the Gantry. The C-arm frame is constructed of two vertical steel rails, which are precision machined to accept the components which it supports. Molded plastic covers enclose the x-ray tube, which is purchased from OEM manufacturers, and the beam limiting device, while aluminum covers enclose the sides, back, top and bottom of the C-arm framework. The C-arm is attached by a locking pivot mechanism to the Gantry. The pivot allows the C-arm to be manually rotated about its axis. The pivot mechanism is attached to the Gantry via a vertically moving carriage. This carriage is capable of movement in the vertical direction, driven by an AC motor and a drive screw mounted to the base of the Gantry. The pivoting action of the C-arm is locked by an electromagnetic brake attached to the vertical carriage, which, in its unactuated condition, prevents rotation. The brake must be electrically actuated to release the C-arm for movement. The Gantry is constructed of a welded steel frame, to which the electrical assemblies and components of the unit are mounted. The operator control is mounted on the side panel of the Gantry, or may be mounted remotely. The input power and input circuit breaker are located on the lower rear panel of the Gantry.

The Lite Touch Erbium Laser Treatment System is intended for the coagulation, vaporization, ablation, or cutting of soft tissue in dermatology and plastic surgery, including aesthetic surgery and resurfacing.

The Lite Touch Erbium Laser is an Erbium:YAG laser which emits its energy at 2.94um.

The Lorad M-Ille Mammography System is intended to produce radiographic images of the breast. Its specific intended use is screening and diagnostic mammography. Screening mammography involves the production of images for initial examination for breast cancer diagnosis. Diagnostic mammography includes the production of magnified images for more thorough examination of areas of the breast determined suspicious through screening mammography, special views, spot compression views, and the production of images used by a physician in preparation for biopsy. Screening and diagnostic mammography, including magnification studies, special views, spot compression views, as well as images used by a physician in preparing for a biopsy.

The Lorad M-IIIe mammoqraphy system is based on Lorad's currently marketed M-III, with changes to add features of Lorad's M-IV. The mechanical package, layout and basic electrical design of the M-III are used, but the x-ray tube of the M-IV, as well as the M-IV user interface and several M-IV software feature algorithms are incorporated. The changes made to the M-III to create the M-IIIe are summarized in the table below. The Lorad M-Ille is a stand alone mammography device, mounted on a base with casters which allow positioning in the room where it is installed. A foot-operated mechanical lock prevents movement during clinical use of the device. The unit is AC powered, and must be connected to a 220 VAC/50-60 hertz (nominal) line to operate. The standalone unit has two major assemblies: the C-arm and the Control Console. An M-Ille configuration tree, identifying the major components and subassemblies that comprise the M-IIIe, is provided in Attachment 1. The C-arm, which contains an x-ray tube, an image receptor support, compression device, a beam limiting device, switches that actuate the C-arm functions, and sensors for detecting installed accessories and making radiation measurements, is attached to the front (patient side) of the machine. The C-arm frame is constructed of two vertical steel rails, which are precision machined to accept the components which it supports. Molded plastic covers enclose the x-ray tube, which is purchased from OEM manufacturers, and the beam limiting device, while aluminum covers enclose the sides, back, top and bottom of the C-arm framework. The bottom panel of the C-arm is spring loaded and attached to a safety switch which disables C-arm vertical movement downward should it contact an object, such as a wheelchair. The C-arm is attached by a locking pivot mechanism to the Control Console. The pivot allows the C-arm to be manually rotated about its central axis. The pivot mechanism is attached to the control console via a vertically moving carriage. This carriage is screw mounted to the base of the Control Console. The pivoting action of the C-arm is locked by an electromagnetic brake attached to the vertical carriage which, in its actuated condition, prevents rotation. The brake is de-actuated to release the C-arm for movement. The Control Console is constructed of a welded steel frame, to which the electrical assemblies and components of the unit are mounted. At the top of the Control Console, an operator station, consisting of a keyboard, a panel of individual pushbuttons and a Liquid Crystal Display (LCD) are mounted. Steel and aluminum panels enclose the Control Console. At the rear of the Control Console, opposite the operator station, there is a input power connector and input circuit breaker. The M-IIIe is equipped with accessories necessary in the performance of mammography. Bucky grid accessories, containing either conventional linear or air-interspaced High Transmission Cellular grids, and a motor system to move the grid during exposure, are provided to reduce the effects of scattered radiation on the image. Compression plates to accommodate different sized patients and different mammographic applications are supplied and are interchangeable by the operator. A magnification table is provided, which provides a means to obtain geometrically enlarged views of suspicious areas of the breast. Footswitches are provided that operate (1) the C-arm vertical position function, to place the breast platform appropriately to the patient's height, and (2) the compression function, allowing the operator to use both hands to position the patient while applying and releasing breast compression position the patient while applying and releasing breast compression. The M-IIIe is capable of use with Lorad's StereoLoc II Breast Biopsy system which was separately cleared by FDA. Use of the M-IIIe with the StereoLoc does not alter the operation of the M-IIIe.