(58 days)
No
The description focuses on the mechanical and electronic components of a traditional mammography system and its performance based on standard phantom and bench tests. There is no mention of AI, ML, or advanced image processing techniques that would suggest the use of such technologies.
No.
The primary purpose of the device is to produce radiographic images for screening and diagnosis, not to provide therapy or treatment.
Yes
The intended use explicitly states "diagnostic mammography," which involves producing images for more thorough examination of suspicious areas and preparation for biopsy, indicating a diagnostic purpose.
No
The device description clearly details a physical mammography system with mechanical and electrical components, including an x-ray tube, C-arm, gantry, and operator controls. It is a hardware device that produces radiographic images.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to produce radiographic images of the breast for screening and diagnostic mammography. This involves imaging the patient directly, not testing samples taken from the patient.
- Device Description: The device is an X-ray system designed to generate and capture X-ray images of the breast. It's a piece of medical imaging equipment used on a living patient.
- Input Imaging Modality: The input is Radiographic, which is an in-vivo imaging technique.
- Anatomical Site: The anatomical site is the breast, which is part of the living patient's body.
- Performance Studies: The performance studies involve imaging phantoms and evaluating the system's ability to produce quality images and perform functions like AEC tracking and stereotactic localization. These are tests of the imaging system itself, not tests of biological samples.
IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or treatment. This device operates on the patient directly to produce images, which is a different category of medical device.
N/A
Intended Use / Indications for Use
The Lorad I-650 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.
Product codes
90 IZH
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiographic
Anatomical Site
Breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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
Not Found
Summary of Performance Studies
Non-Clinical Testing: A series of bench tests were performed to assess the mammographic imaging performance.
- Focal Spot Performance Testing:
- Measurement Method: 0.5° and 1.5° star patterns were imaged with the center located approximately 1 cm from the chest wall. Images were made at 25, 28, and 30kV. Background optical density was 1.2 to 1.4 OD. Kodak MinR-2000 film and screens were used with 90-second Kodak chemistry developing.
- Pass Criteria (NEMA method): Large focal spot (nominal 0.3 mm): Maximum dimensions = 0.45mm W x 0.65mm L. Small focal spot (nominal 0.1 mm): Maximum dimensions = 0.15mm W x 0.15mm L.
- Results:
| Focal Spot | kV | Length (mm) | Width (mm) |
|---|---|---|---|
| Large | 25 | 0.47 | 0.33 |
| Large | 28 | 0.46 | 0.31 |
| Large | 30 | 0.46 | 0.30 |
| Small | 25 | 0.11 | 0.087 |
| Small | 28 | 0.11 |
§ 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
3 1999 SEP
K92280
Section Seven - 510(k) Summary
7.1 Submitter
Lorad Division of Trex Medical Corporation 36 Apple Ridge Road Danbury, Connecticut 06810
Contact: Philip G. Juhas
203-790-1188
7.2 Device Identification
1-650 Mammography System Mammographic X-ray System 21 CFR 892.1710
Legally Marketed Device to Which Substantial Equivalence is Claimed: Lorad D-550 Mammographic X-ray System (K934870) and Lorad Elite Mammographic X-ray System (K973631).
7.3 Device Description
7.3.1 Intended Use
The Lorad I-650 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 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 changes made to the Elite to create the 1-650 are summarized in the table below.
1
| Elite
Specification | Change | I-650
Result |
|-----------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| LCD panel display and standard
QWERTY keyboard for user
interface | LCD panel display with cursor
and input keys used for technique
and function selections. | User interface duplicates the
Lorad Elite Functions. |
| Automatic Exposure Modes:
• Auto-Time
• Auto-kV
• Auto -Filter | Automatic Exposure Modes:
• Auto-Time
• Auto-kV | Subset of Elite modes |
| X-ray Tube: .1/.3 mm focal spots
10° target angle small focal spot,
16 degree target angle large focal
spot. | .1/.3 mAs focal spots,
16° Target angle | 80 mA LF, 20 mA SF |
| Automatic Exposure Detector:
• Averaged over three
separate cells | Automatic Exposure Detector:
• Averaged over three
separate cells | • Same |
| Compression Thickness and
compression force indicated with
digital display. | Compression Thickness and
compression force indicated with
digital display. | • Same. |
7.3.3 Construction
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. An I-650 configuration tree, identifying the major components and subassemblies that comprise the I-650, is provided in Attachment B. 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
2
may be mounted remotely. The input power and input circuit breaker are located on the lower rear panel of the Gantry.
7.3.4 Compatible Equipment
The I-650 is equipped with accessories necessary in the performance of mammography. Bucky accessories, are provided to reduce the effects of scattered radiation on the image. Compression paddles to accommodate different sized Buckies and different mammographic applications are supplied. Thev 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.
The 1-650 is capable of use with Lorad's StereoLoc II Breast Biopsy system which was separately cleared by FDA (K952210). Use of the 1-650 with the StereoLoc II does not alter the operation of the 1-650. The 1-650 will be configured for application in a mobile van.
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) |
3
Duty Cycle:
Full load 5 seconds on, 30 seconds off (1:7)
7.3.5.2 Dimensions
| Height: | 70 inches (178 cm.) |
|---|---|
| Width: | 24 inches (60 cm.) |
| Depth: | 39.75 inches (100 cm.) |
| Weight: | 660 lb. (300 kg) approximate |
7.3.5.3 Operating Environment
| Temperature Range: | 10° C. to 40° C. |
|---|---|
| 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 |
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 |
4
Vertical Travel: 26 to 55 inches (66-140 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 xray 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:
Full compression: provides compression in a range of 20-40 lb., user selected
Note: motorized compression to be limited to 40 lb.
- B. Control: C-arm pushbuttons or 2 position footswitch
- 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.
- D. Release Distance: Automatic release shall move the compression device a distance of 15 cm.
5
- 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: manual 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 greater than 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 PETg. 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.
- Magnification is provided using either a plateform Magnification: assembly or a table assembly.
- 1.8x for objects 22.5 mm above the magnification A. Maqnification Factor: stand breast support surface (the breast support surface will be at approximately 1.7x)
- B. Material of Breast Support Surface: Transparent polycarbonate or carbon fiber composite.
- C. Size of Breast Support Surface:
15 cm wide x 12 cm deep for table construction, or 18x24 cm for the plateform construction.
7.3.5.6 Image Receptor Support Device
The IRSD contain sensors for accessory detection and houses the 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 (1 uGy) for the maximum technique exposure to comply with 21 CFR 1020.31 and IEC 601-1-3. Section 29.207.2.
7
7.3.5.7 X-ray Source Insert Specifications
| X-ray Tube: | Varian model M185L/B115 |
|---|---|
| Focal Spot Size: | Large 0.3 mm, Small 0.1 mm, nominal NEMA/IEC. |
| 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 will provide a system resolution of equal to | |
| or greater than 13 lp/mm in the width dimension and | |
| 11 Ip/mm in the length dimension as measured per | |
| the ACR/Quality Control Manual protocol. | |
| Tube Voltage: | 22 kVp to 39 kVp maximum |
| Tube Current: | Large Focus - 80 mA max. |
| Small Focus - 20 mA max. | |
| Anode Rotation: | 3400 rpm (standard speed)/60Hz |
| 2800rpm (standard sped)/50Hz |
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.
16°
- D. Maximum Housing Heat Dissipation Rate: 72 W (6 kHU/min) without air-circulator, 300 W (25 kHU/min) with air cooling
Anode Angle:
8
Anode Material:
Molybdenum
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 theTube Housing Surface: 55° C.
Maximum Temperature of the Tube Head Cover Surface: 41° C.
Over Temperature Protection Sensor: Internally provided in series with stator common
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