(90 days)
Not Found
Not Found
No
The document describes a traditional mammography system with mechanical and electrical components, software algorithms for basic functions like AEC tracking, and a user interface. There is no mention of AI, ML, deep learning, or any algorithms that learn from data to perform tasks like image analysis or diagnosis. The performance studies focus on image quality, system accuracy, and compliance with standards, not on the performance of AI/ML algorithms.
No
The device is intended to produce radiographic images for diagnosis, not to provide therapy or treatment.
Yes.
This device is intended for "screening and diagnostic mammography", explicitly stating its role in diagnosing breast cancer and providing magnified images for "more thorough examination of areas of the breast determined suspicious through screening mammography".
No
The device description clearly indicates it is a physical mammography system with hardware components such as an x-ray tube, C-arm, control console, and various mechanical and electrical assemblies. While it incorporates software features, it is not solely software.
Based on the provided information, the Lorad M-IIIe Mammography System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The Lorad M-IIIe Mammography System produces radiographic images of the breast using X-rays. It does not analyze biological specimens.
- Intended Use: The intended use is to produce images for screening and diagnostic mammography, which involves imaging the breast directly, not analyzing samples from the breast.
- Device Description: The description details the physical components of an X-ray imaging system, not equipment for handling or analyzing biological samples.
- Performance Studies: The performance studies focus on image quality, resolution, and system accuracy in positioning and exposure, which are relevant to an imaging device, not an IVD.
Therefore, the Lorad M-IIIe Mammography System is an imaging device, specifically a mammography system, and not an IVD.
N/A
Intended Use / Indications for Use
The Lorad M-IIIE 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.
Product codes (comma separated list FDA assigned to the subject device)
90 IZH
Device Description
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 prot meonlaniem is attached the of movement in the vertical direction, driven by ournage. "This camage is crew mounted to the base of the Control Console. an AS motor and a of the C-arm is locked by an electromagnetic brake attached r ne proting action of the mactuated condition, prevents rotation. The to the vertion sumaged 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..
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician / Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Bench tests
Sample Size: Not found
AUC: Not found
MRMC: Not found
Standalone Performance:
- System Resolution:
- Focal Spot Measurement:
- Large Focal Spot: Test 1 (Width=0.43, Length=0.48), Test 2 (Width=0.43, Length=0.49). Pass Criteria (NEMA method): maximum dimensions = 0.45 W x 0.65 L.
- Small Focal Spot: Test 1 (Width=0.09, Length=0.12), Test 2 (Width=0.09, Length=0.12). Pass Criteria (NEMA method): maximum dimensions = 0.15 W x 0.15 L.
- Line Pair Evaluation:
- Large Focal Spot: Film 1 (Parallel=15 lp/mm, Perpendicular=12 lp/mm), Film 2 (Parallel=15 lp/mm, Perpendicular=13 lp/mm). Pass Criteria (ACR): Parallel - 13 lp/mm, Perpendicular - 11 lp/mm.
- Small Focal Spot: Film 3 (Parallel=16 lp/mm, Perpendicular=13 lp/mm), Film 4 (Parallel=16 lp/mm, Perpendicular=13 lp/mm). Pass Criteria (ACR): Parallel - 13 lp/mm, Perpendicular - 11 lp/mm.
- Focal Spot Measurement:
- Object Phantom Tests:
- RMI-156 phantom images scored:
- Fibers: Phantom Film 1 (5.5), Phantom Film 2 (5.5). ACR/MQSA Minimum: 4.
- Specks: Phantom Film 1 (3.5), Phantom Film 2 (3.5). ACR/MQSA Minimum: 3.
- Masses: Phantom Film 1 (4), Phantom Film 2 (4). ACR/MQSA Minimum: 3.
- Total Score: Phantom Film 1 (13), Phantom Film 2 (13). ACR/MQSA Minimum: 10.
- Mean Glandular Dose: Phantom Film 1 (1.84 mGy), Phantom Film 2 (1.84 mGy). ACR Limit: 3 mGy.
- Optical Density: Phantom Film 1 (1.39), Phantom Film 2 (1.41).
- Contrast Diff. Ratio (Avg. density - contrast disk): Phantom Film 1 (0.42), Phantom Film 2 (0.44). ACR Requirement: 0.40 approximate.
- RMI-156 phantom images scored:
- AEC Tracking:
- Optical density of any film to be within ±0.15 of the average OD for all the test images. Results for Automatic Exposure Control Tracking meet the specification, with an average optical density of 1.36.
- Stereotactic evaluation:
- Needle Positioning and Targetting Test (StereoLoc II - DSM Equipped, 512 mode): Cumulative Error = sqr(Xerr2+Yerr2+Zerr2)=0.6. Specified Accuracy ±1 mm. Results meet specification.
- Needle Positioning and Targetting Test (StereoLoc II - DSM Equipped, 1024 mode): Cumulative Error = sqr(Xerr2+Yerr2+Zerr2)=0.6. Specified Accuracy ±1 mm. Results meet specification.
- Needle Positioning and Targetting Test (StereoLoc II - Film Equipped): Cumulative Error = sgr(Xerr +Yerr +Zerr2)= 0.68. Specified Accuracy ±1 mm. Results meet specification.
Key Results: The tests demonstrate that the M-IIIE system meets or exceeds the specified performance criteria for resolution, image quality as evaluated by phantom studies, AEC tracking, and is compatible with stereotactic localization procedures using the StereoLoc II device (both DSM and film equipped).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Linearity: (radiation output versus selected mAs) 0.10 for adjacent mAs selections per the following (X1-X2)=to or less than 0.10(X1+X2) where X1 and X2 are average mR/mAs values for consecutive exposures (21CFR) Internal specification 0.09.
Accuracy: kVp - the actual value will not differ by more than 1 kV from the indicated value. The difference between 2 actual kV stations will be in compliance with the difference of the indicated values. mAs: ±5% from indicated, Post-mAs: ±5% from actual.
Reproducibility: 0.05 coefficient of variation for 10 consecutive exposures (21 CFR) Internal specification 0.04.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Lorad M-III Mammographic X-ray System, Lorad M-IV Mammographic X-ray System. (Note: These are device names, not K/DEN numbers, as they appear in the text.)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1710 Mammographic x-ray system.
(a)
Identification. A mammographic x-ray system is a device intended to be used to produce radiographs of the breast. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
Section Seven - 510(k) Summary
DEC 2 3 1997
7.1 Submitter
Lorad Division of Trex Medical Corporation 36 Apple Ridge Road Danbury, Connecticut 06810
Contact: P.G. Juhas
203-790-1188
7.2 Device Identification
M-IIIE Mammography System Mammographic X-ray System 21 CFR 892.1710
Legally Marketed Device to Which Substantial Equivalance is Claimed: Lorad M-III Mammographic X-ray System and Lorad M-IV Mammographic X-ray System.
7.3 Device Description
7.3.1 Intended Use
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.
7.3.2 Design
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.
1
| M-III
Specification | Change | M-Ille
Result |
|----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| CRT Display and custom keypads
for user interface | LCD panel display and standard
QWERTY keyboard for user
interface | User interface duplicates the
Lorad M-IV |
| Separate unit suspended on an
attached shelf flashes
identification data onto the film | Film flasher unit built into frame
and covers of the mammography
unit. | Film flashing function now
integrated into the unit package |
| Automatic Exposure Modes:
• Auto-Time
• Auto-kV | Automatic Exposure Modes:
• Auto-Time
• Auto-kV
• Auto-Filter | Automatic exposure modes
include the filter selection (Mo or
Rh) capability employed in the M-
IV |
| X-ray Tube: .1/.3 mm focal spots;
16° target angle. | X-ray Tube: .1/.3 mm focal spots
10° target angle small focal spot,
16 degree target angle large focal
spot. | Increases small focal spot tube
current capability from 20 mA to
28 mA. |
| Automatic Exposure Detector:
• Single cell | Automatic Exposure Detector:
• Averaged over three
separate cells | Greater area of tissue sampled
for controlling exposure density. |
| Only Compression Thickness
indicated | Compression Thickness and
compression force indicated with
digital display. | Meets MQSA/ACR requirements |
| Light Field Mirror in x-ray path
during exposure | Light Field mirror removed from x-
ray path during exposure | Removes source of artifacts and
eliminates effects on beam
characteristics |
7.3.3 Construction
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
2
pivot mechanism is attached to the control console via a vertically moving prot meonlaniem is attached the of movement in the vertical direction, driven by ournage. "This camage is crew mounted to the base of the Control Console. an AS motor and a of the C-arm is locked by an electromagnetic brake attached r ne proting action of the mactuated condition, prevents rotation. The to the vertion sumaged 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.
7.3.4 Compatible Equipment
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..
3
7.3.5 Physical and Functional Specifications
7.3.5.1 Electrical Input
| Mains Voltage: | 200/208/220/230/240 VAC nominal, ±10%, 50/60 Hz |
|---|---|
| Mains Impedance: | Maximum line impedance not to exceed 0.25 ohms |
| Maximum Power Consumption: | 4.4 KVA for 5 seconds duration |
| Standby Power: | 0.50 KVA nominal |
| Maximum Line Current: | 25 amps for 5 seconds |
| Circuit Breaker Rating: | 15A, time delay curve to allow for inrush currents |
| (200% overload for 7 seconds) | |
| Duty Cycle: | Full load 5 seconds on, 30 seconds off (1:7) |
7.3.5.2 Dimensions
::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::
| Height: | 77 inches (196 cm.) |
|---|---|
| Width: | 60.25 inches (64.7 cm.) |
| Depth: | 25.5 inches (153 cm.) |
| Weight: | 700 lb. (317.5 kg) approximate |
7.3.5.3 Operating Environment
| Temperature Range: | 10° C. to 40° С. |
|---|---|
| Relative Humidity Range: | 30% to 75% non-condensing |
| ESD Susceptibility: | Level of 3 kV for contact discharge to conductive accessible parts that are not grounded. A level of 8 kV for air discharge to all accessible parts. Test Methods IEC 801-2, Test Level: IEC 601-1-2 |
| EMI Susceptibility: | The system shall be immune from levels of 1 v/m for the frequency range of 26 mHz to 1 gHz (IEC 801-3) |
| EMI Generation Limits: | System shall comply with the requirements of CISPR 11 for conducted and radiated emission |
| Input Line Protection: | Surge, fast transient/burst, lightning, IEC 801-4, IEC 801-5 |
4
7.3.5.4 Storage Environment
Temperature Range:
| -25° C. to +60° C. | |
|---|---|
| Humidity: | 0 to 95% RH (non-condensing) - not packaged for outdoor storage. |
7.3.5.5 Mechanical Specifications
| C-arm Rotation: | +195° to 0° to -150° with detents at 0°, ±45°, ±90°,
±135° and +180°. |
|-----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Rotation Lock: | Electromagnetic |
| Vertical Travel: | 28 to 56 inches (71-142 cm) from surface of Bucky to
floor at 0° |
| Alignment of Focal Spot, Compression Device and Image Receptor: | The focal spot of the x-ray tube shall be located such
that the ray falling on the edge of the image receptor
closest to the chest wall is perpendicular to the image
receptor. The system shall allow the plane formed by
the focal spot and the chest wall of the device shall
be perpendicular to that ray, and motion of the
compression device shall provide essentially parallel
compression of the breast with respect to the plane of
the image receptor. The compression paddle and x-
ray tube shall be adjustable, chest wall to nipple, to
provide for this alignment requirement. |
| Source to Image Distance | |
65 cm (measured from nominal position of film in Bucky to the large focal spot.
Compression
A. Force
- a. Manual Compression: shall be limited to 65 lb. ±7 lb. maximum
b. Motorized Compression:
shall function in two user selectable operating modes (1) Pre-compression: provides compression in a range of 15-30lb., user-selected (2) Full compression: provides compression in a range of 20-40 lb., user selected
Note: motorized compression must be limited to 40 lb. in either mode.
5
- C-arm pushbuttons or 2 position footswitch B. Control: C. Compression Release: Motorized, initiated by pushbutton controls on C-arm and on operator panel. Automatic release enabled by software to release at end of exposure, unless inhibited by presence of localization paddle. Automatic release shall move the compression device D. Release Distance: a distance of 15 cm., although in mag mode, this distance may be less. After compression applied, backdrive of device shall E. Backdrive: not exceed 1.5 mm in either motorized or manual modes between -90°, 0°, and +90° C-arm positions, and no greater than 3 mm in any C-arm position outside that range. In the event of a power failure, there will be means for F. Failure Mode: release of compression Vertical C-arm drive and C-arm rotation will be G. Movement Interlock: disabled if there is approximately 10 lb. or more of compression force. H. Compression Force Display: Located on upper cover of compression device in combination with compression thickness and AEC detector position. I. Compression Force Display Accuracy: ±3 lb. from 10 lb. to 35 lb. (±13.35 N from 44.5 N to 155.75 N): ±5 lb. Above 35 lb. (±22.25 N above 155.75 N); J. Compression Thickness Measurement and Display: Thickness shall be measured between 0 and 15 cm above the image receptor and displayed. The display shall be compensated for the type of image receptor installed. Display will be in 0.1 cm increments on compression device cover and on user interface screen.
- K. Compression Thickness Accuracy:
±0.5 cm. at thickness between 0.5 and 10 cm. ±0.8 cm. at thickness between 0.5 and 10 cm.
6
- L. Compression Paddles: the compression paddles will be transparent and marked with the location of the AEC sensor positions. The composition shall be either polycarbonate or PETq. The sensor position marking shall not be detectable on film when imaged with 1 cm of acrylic attenuator at 22 kVp to an optical density of 1.2 OD. The paddle attenuation shall be less than 15% (reduction OF mR/mAs) AT 25 kVp. The paddles will be designed to provide a parallel plane to the image receptor under 40 lb. Of compression force. The paddles will be adjustable to provide the focal spot, compression device and image receptor alignment requirement expressed previously.
- the magnification table will be constructed as a tower Magnification to provide rigidity. Alternatively, it will be a platform suspended from hangers on the C-arm.
- 1.8x for objects 22.5 mm above the magnification A. Magnification Factor: stand breast support surface (the breast support surface will be at approximately 1.7x)
- B. Material of Breast Support
Transparent polycarbonate or carbon fiber composite. Surface:
- C. Size of Breast Support Surface:
15 cm wide x 12 cm deep for table construction, or 18x24 cm for alternate construction.
7.3.5.6 Image Receptor Support Device
It will contain sensors for accessory detection. It will also provide space for the existing 3 cell AEC detector moveable to 7 positions at 1.7 cm. increments. The image receptor support device shall limit the x-ray transmission to no more than 0.1 mR for the maximum technique exposure to comply with 21 CFR, section 1020.31 and shall meet the 1 uGy per exposure as defined by IEC 601-1-3. Section 29.207.2.
7
7.3.5.7 X-ray Source Insert Specifications
Varian model B113/B115 X-rav Tube: Toshiba model E7290AX Large 0.3 mm, Small 0.1 mm, nominal NEMA/IEC; Focal Spot Size: the focal spot will be measured at a reference angle defined at 6° from the perpendicular, or chestwall, ray. The tube will be tilted 6° with a target angle of 16° to result in a total target angle to image plane angle of 22°. This reference angle is then the actual central ray of the x-ray tube. This must provide a system resolution of equal to or greater than 13 Ip/mm in the width dimension and 11 Ip/mm in the length dimension as measured per the ACR/CDC protocol. Tube Voltage: 22 kVp to 39 kVp maximum
| Tube Current: | Large Focus - 80 mA between 22 and 28 kVp |
|---|---|
| Small Focus - 28 mA between 25 and 28 kVp | |
| Operating speed of 3400 rpm (standard speed) |
Thermal Characteristics:
| A. Anode Heat Storage : 210 kJ (300 kHU) |
|---|
| B. Maximum Anode Heat Dissipation Rate: |
525 W (740 HU/s)
-
C. Housing Heat Storage Capacity:
610 kJ (860 kHU) min. -
D. Maximum Housing Heat Dissipation Rate:
72 W (6 kHU/min) without air-circulator, 300 W (25 kHU/min) with air cooling -
50/60 Hz., 3000/3600 rpm Anode Rotation:
-
Anode Angle: The x-ray tube will have a bi-anqle anode with the large focal spot on a 10° angle. The tube will be tilted at a 6° angle to provide a 22° anode to film plane angle for the large and 16° anode to film plane angle for the small. This provides film of 24x30 cm for the large and 18x24 cm. for the small (magnification).
. '
Anode Material: Molybdenum
8
X-ray window:
Beryllium, 0.8 mm thickness maximum
:,
X-ray Tube Housing and Tube Head Cover
Continuous Heat Dissipation: 300 watts
Maximum Temperature of the Tube Housing Surface: 55° C.
Maximum Temperature of the Tube Head Cover Surface:41° C.
Over Temperature Internally provided in series with stator common Protection Sensor:
Safety Class: IEC 601-2-28
7.3.5.9 X-ray Beam Filtration
| Inherent Filtration: | 0.0 mm Al equivalent |
|---|---|
| Added Filtration: | 30 microns Molybdenum foil, or |
| 25 microns Rhodium foil | |
| Beam Quality: | At a given kilovoltage, the measured HVL for Mo/Mo |
| operation with the compression paddle in the x-ray | |
| beam will be equal to or greater than the value of | |
| kVp/100+0.03 in units of mm of aluminum but less | |
| than the value of kVp/100+0.12 in units of mm of | |
| aluminum. For Mo/Rh, min>kVp/100+0.03, | |
| Max |