(210 days)
Not Found
No
The document describes a digital stereotactic biopsy attachment system for mammography, focusing on hardware components, image processing functions (like zoom, contrast, filters), and its intended use for small field imaging during biopsy and localization. There is no mention of AI, ML, deep learning, or any related concepts in the provided text.
No
Explanation: The device is described as an imaging system used for stereotactic biopsy and spot localization, which are diagnostic procedures, not therapeutic ones.
Yes
The device is an x-ray system used for small field mammographic x-ray imaging, specifically for stereotactic biopsy and spot localization. These applications involve imaging to aid in diagnosis or guide procedures, making it a diagnostic device.
No
The device description explicitly lists multiple hardware components including a camera assembly (CCD detector), biopsy unit, workstation, modem, MO drive, trolley, and Biopsy controller, in addition to software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "small field mammographic x-ray imaging" used during "stereotactic biopsy and spot localization." This describes an imaging system used during a medical procedure (biopsy), not a test performed on a biological sample in vitro (outside the body).
- Device Description: The description details an x-ray system with a detector, biopsy unit, workstation, and software for image display and processing. This is consistent with an imaging and guidance system for a procedure.
- Input Imaging Modality: The input is "Mammographic X-ray," which is an imaging technique, not a method for analyzing biological samples.
- Anatomical Site: The anatomical site is "Breast," which is the target for the imaging and biopsy procedure.
IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment. This device is used to visualize and guide a procedure on the body itself.
N/A
Intended Use / Indications for Use
The Siemens Digital Stereotactic Biopsy Attachment System (DSBAS) marketed as OPDIMA (Optimized Digital Mammography) is a digital small field x-ray option for the commercially available Mammomat 3000 mammographic x-ray system. The Mammomat 3000 with DSBAS option is intended for use in small field mammographic x-ray imaging. Such small field imaging is used during stereotactic biopsy and spot localization.
Product codes
Not Found
Device Description
The fully functional OPDIMA mammographic x-ray system configuration consists of the commercially available Mammomat 3000 mammographic x-ray system configured with the DSBAS (Digital Stereotactic Biopsy Attachment System) option. The Mammomat 3000 with DSBAS option is a Digital Stereotactic Biopsy Mammography System intended for use in small field digital mammographic examinations. The Mammomat 3000 with the DSBAS option consists of the Mammomat 3000 stand and generator configured with a camera assembly, i.e., CCD detector, biopsy unit and a workstation for the display and processing of images, modem, MO drive, trolley, Biopsy controller and DSBAS software (Application Software and Biopsy Controller software).
The user can select three modes of operation, Spot, biopsy or normal (non-digital) mode. The system is designed with key image processing functions, Zoomfactor, Magnifying Glass, Contrast Enhancement, Image invert, Histogram, Electronic ruler and image filter. Zoomfactor and Magnifying glass provide 2x, 4x and 8x magnification. For image filtering, five image filters are selectable. The Histogram feature displays the population for each grey scale value.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Mammographic X-ray
Anatomical Site
Breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained healthcare professional / 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Mammovision DSM, K952136, DSM - Digital Stereomammography System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
SIEMENS
510 (k) SUMMARY
I. GENERAL INFORMATION: Establishment:
- Address:
MAY - 8 1997
· Registration Number:
•Contact Person:
Siemens Medical Systems, Inc. 186 Wood Avenue South Iselin, NJ. 08830
2240869
Kathleen Rutherford Manager, Regulatory Submissions Telephone: (908) 321- 4779 TELEFAX: (908) 321 - 4841
Date of Summary Preparation:
Device Name: · Trade Name:
OPDIMA Mammographic X-ray System Mammomat 3000 with DSBAS (Digital Stereotactic Attachmant System)
Mammographic X-ray System
Mammographic X-ray System
·Common Name:
· Classification Name:
·Classification:
Class II
Performance Standards:
21 CFR, Subchapter J
All system components to which the above standard applies are certified to conform with 21 CFR subchapter J
II. SAFETY AND EFFECTIVENESS INFORMATION SUPPORTING THE SUBSTAN-TIAL EQUIVALENCE DETERMINATION.
Device Description:
The fully functional OPDIMA mammographic x-ray system configuration consists of the commercially available Mammomat 3000 mammographic x-ray system configured with the DSBAS (Digital Stereotactic Biopsy Attachment System) option. The Mammomat 3000 with DSBAS option is a Digital Stereotactic Biopsy Mammography System intended for use in small field digital mammographic examinations. The Mammomat 3000 with the DSBAS option consists of the Mammomat 3000 stand and generator configured with a camera assembly, i.e., CCD detector, biopsy unit and a workstation for the display and processing of images,
Siemens Medical Systems, Inc.
Imaging Systems Group
1
SIEMENS
modem, MO drive, trolley, Biopsy controller and DSBAS software (Application Software and Biopsy Controller software).
The user can select three modes of operation, Spot, biopsy or normal (non-digital) mode. The system is designed with key image processing functions, Zoomfactor, Magnifying Glass, Contrast Enhancement, Image invert, Histogram, Electronic ruler and image filter. Zoomfactor and Magnifying glass provide 2x, 4x and 8x magnification. For image filtering, five image filters are selectable. The Histogram feature displays the population for each grey scale value.
Intended Use:
The Siemens Digital Stereotactic Biopsy Attachment System (DSBAS) marketed as OPDIMA (Optimized Digital Mammography) is a digital small field x-ray option for the commercially available Mammomat 3000 mammographic x-ray system. The Mammomat 3000 with DSBAS option is intended for use in small field mammographic x-ray imaging. Such small field imaging is used during stereotactic biopsy and spot localization. Technological Characteristics:
The DSBAS mammographic X-ray system consists of the Mammomat 3000 configured with the DSBAS (Digital Stereotactic Biopsy Attachment System) Option . The major system components consist of the Mammomat 3000 X-ray stand and generator, CCD detector, biopsy unit, Biopsy controller, DSBAS system software and workstation. The CCD detector has an imaging area of 49 x 85 mm. The pixel sizes vary according to the mode of operation; 24 um in spot mode and 48 um stereo mode. The pixel matrices are 2048 x 3584 pixel in spot mode and 1024 x 1792 pixel in stereo mode with a pixel depth of 12 bits. The image resolution is ≥ 10 lp / mm in stereo mode and ≥ 11 lp/mm in spot mode.
The DSBAS workstation is a 32 bit, 140 Mhz processor with 64 MB RAM, 32 kB and 2GB hard disk. The monitor has a resolution of 1024 x 1280 with 8-bit pixel depth. The system is equipped 2GB hard disc for archiving of approximately 500 images and optional disc achiving of 2.6 GB (250 images in spot mode and 1000 images in biopsy mode) per additional disc.
General Safety and Effectiveness Concerns:
Instructions for use are included within the device labeling and the information provided will enable the trained healthcare professional to operate the device in a safe and efficacious manner. Furthermore the operators are health care professionals familiar with and responsible for the X-ray examinations to be performed. To minimize electrical, mechanical and radiation hazards, Siemens adheres to recognized and established industry practice, and all equipment is subject to final performance testing.
2
SIEMENS
Substantial Equivalence:
In the opinion of Siemens Medical Systems, Inc., Mammomat 3000 with the In the opinion of Sleated Systems and substantially equivalent to the following
DSBAS option is of comparable type and substantially equivalent to the following D5BA3 option is of comparable type and substance)
currently marketed Small Field Digital Mammographic X-ray Systems:
Predicate Device
Manufacturer
Mammovision DSM
Fischer Imaging, Inc. Lorad, Inc.
Kathleen Rutherford
Kathleen Rutherford Manager, Regulatory Submissions
10/8/96
Date