(88 days)
Not Found
No
The summary describes a digital imaging system with image processing capabilities, but there is no mention of AI, ML, or related terms like neural networks or deep learning. The focus is on digital subtraction and high-resolution imaging using conventional components like a CCD camera and video processor.
No.
The device's description and intended use focus on enhancing imaging quality, replacing conventional imaging methods, and reducing radiation exposure and examination time; it does not describe any direct therapeutic action on the patient.
No
The device is an imaging system designed to enhance fluoroscopy images and acquire radiographic images, not to diagnose medical conditions directly. While it assists in diagnostic procedures by providing clearer images, it does not perform the diagnosis itself.
No
The device description explicitly lists hardware components such as a computer workstation, CCD camera, video processor, monitors, interfaces, and a hard disk, indicating it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Function: The SMARTSPOT is a system designed to enhance and acquire radiographic and fluoroscopic images. It processes and displays images obtained from X-ray procedures performed on the patient's body.
- Lack of Sample Analysis: The description does not mention the analysis of any biological samples taken from the patient.
The SMARTSPOT is a medical imaging device used for diagnostic purposes, but it operates by processing images generated by external radiation (X-rays) interacting with the patient's body, not by analyzing samples in vitro.
N/A
Intended Use / Indications for Use
The SMARTSPOT enhances the quality of the fluoroscopy image, enables acquisition and display of high resolution (1024 x 1024 pixels) radiographic images and gives the user the possibility to perform advanced studies involving image digital subtraction, such as Roadmapping and DSA, that were not possible with conventional techniques.
Fields of application of the system are: gastrointestinal examinations, interventional procedures, peripheral angiography studies, urology examinations and other routine fluoroscopy studies.
Product codes
Not Found
Device Description
The SMARTSPOT is a high resolution digital system for Digital Spot Imaging in Radiography/Fluoroscopy (R/F) X-ray rooms. It is designed to reduce (and even replace) the use of cassette filming and 105 mm spot cameras, and in this way reduce overall patient radiation exposure and examination time.
The system is based on a computer workstation running Windows NT as the operating system. The other main components are: a high resolution CCD camera, an advanced video processor, operation room and control room monitors, X-ray and TV interfaces, Hardcopy Laser Camera interface and a 2 GBytes internal hard disk.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiography/Fluoroscopy (R/F) X-ray
Anatomical Site
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
CIVIL
MEDICAL TECHNOLOGIES LTD
JU - 1 1996
510(k) Summary of Safety and Effectiveness
Submitter Information
-
Submitter: CMT Medical Technologies Ltd. MATAM, Haifa 31905 Israel
Establishment Reg .: 9680763 -
Contact: Imre Farkash Quality Assurance Manager
-
Summary Date: April 21, 1996
Name of Device and Classification
Proprietary Name: SMARTSPOT
Common Name: High Resolution Digital Imaging System
Classification: Accessory to 21 CFR 892.1650, Class II
Predicate Device
Manufacturer: S & S Inficon Inc.
Predicate Name: FC 2000
510(k) number: K911454
Description of the Device
The SMARTSPOT is a high resolution digital system for Digital Spot Imaging in Radiography/Fluoroscopy (R/F) X-ray rooms. It is designed to reduce (and even replace) the use of cassette filming and 105 mm spot cameras, and in this way reduce overall patient radiation exposure and examination time.
The system is based on a computer workstation running Windows NT as the operating system. The other main components are: a high resolution CCD camera, an advanced video processor, operation room and control room monitors, X-ray and TV interfaces, Hardcopy Laser Camera interface and a 2 GBytes internal hard disk.
1
Intended Use
The SMARTSPOT enhances the quality of the fluoroscopy image, enables acquisition and display of high resolution (1024 x 1024 pixels) radiographic images and gives the user the possibility to perform advanced studies involving image digital subtraction, such as Roadmapping and DSA, that were not possible with conventional techniques.
Fields of application of the system are: gastrointestinal examinations, interventional procedures, peripheral angiography studies, urology examinations and other routine fluoroscopy studies.
Comparison to the Predicate
Both systems have the same intended use. They have almost identical features, same spatial resolution and same digitization depth.
Both systems are computer controlled devices, although different platforms and different operating systems but both in the mainstream of today's computer technology. The main and almost only relevant difference is the TV camera used: the SMARTSPOT integrates a digital CCD camera vs. the Pick-up tube type used by the predicate device. CCD cameras are already widely used in fluoroscopic digital devices. These cameras show a comparable spatial resolution and dynamic range as the pick-up tube counterparts but thev outperform them in terms of cost-effectiveness and long term stability.
Safety information
The device is designed to comply at least with the minimum response requirements stated in the initial Hazard Analysis included in this notification, and with voluntary international standard IEC 601-1 for medical electrical equipment regarding both its safety (part 1) and electromagnetic compatibility (part 2) requirements.
After completion of the pre-production series, the device will be submitted for compliance tests with the above mentioned requirements in a certified laboratory. Prior to commercial distribution, the system will be ß tested to meet specifications including safety requirements.
Conclusion
We conclude that, once finished the development and testing phase as described, the SMARTSPOT will be as safe and effective as the predicate device.
Atalhafi
Imre Farkash Quality Assurance Manager
April 21, 1996
date
te