(29 days)
Not Found
No
The document describes a digital imaging system with image processing capabilities (digital subtraction) but does not mention AI, ML, or related terms, nor does it describe any features or functions typically associated with AI/ML in medical imaging (e.g., automated detection, segmentation, or analysis based on learned patterns). The focus is on improving image quality and enabling advanced studies through digital techniques.
No
The device is described as an "imaging system" that "enhances the quality of the fluoroscopy image" and enables "acquisition and display of high quality resolution radiographic images." Its applications are for "examinations" and "studies," not for directly treating a disease or condition.
No.
The device enhances the quality of fluoroscopy images and enables the acquisition and display of radiographic images for examinations and procedures. It does not provide a diagnosis itself, but rather improves the imagery used by a clinician for diagnosis.
No
The device description explicitly states it is a "high-resolution digital imaging system" based on a "PC Workstation" and mentions "aging technologies and components (hardware and software) have been redesigned," indicating it includes hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as enhancing and acquiring medical images (fluoroscopy and radiographic) for various clinical procedures (gastrointestinal, interventional, angiography, urology, etc.). This is a function related to medical imaging and diagnosis based on visual interpretation of images, not on testing samples of human origin.
- Device Description: The description confirms it's a digital imaging system for Digital Spot Imaging, based on a PC workstation. This aligns with medical imaging equipment.
- No mention of testing samples: There is no indication that this device is used to test samples of human origin (like blood, urine, tissue, etc.) to provide information about a physiological state, health, or disease.
IVD devices are specifically designed to perform tests on biological samples to provide diagnostic information. This device is focused on acquiring and processing medical images.
N/A
Intended Use / Indications for Use
The SmartSPOT PrimaX enhances the quality of the fluoroscopy image, enables acquisition and display of high quality resolution (1024X1024 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 technique.
Fields of application of the system are: gastrointestinal examinations, interventional procedures, peripheral angiography studies, urology examinations and other routine fluoroscopy studies.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
The SmartSPOT PrimaX is a high-resolution digital imaging system designed for Digital Spot Imaging. The system is based on a PC Workstation running Windows XT as the operating system. The legally marketed SMARTSPOT K961307 has been modified: To improve its cost effectiveness, aging technologies and components (hardware and software) have been redesigned. The device major functions and principle of operation were not changed.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopy, Radiographic
Anatomical Site
Gastrointestinal, Peripheral Angiography, Urology
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The device has been designed verified and validated complying with 21 CFR 820.30 regulations. Tests data demonstrate that the SMARTSPOT PrimaX meets the required specifications. No adverse affects have been detected.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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
§ 892.2050 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
Koro890
510(k) Summary of Safety and Effectiveness (in accordance to 21 CFR 807.87(h))
Device Name
Proprietary Device Name: SmartSPOT PrimaX
Establishment Name and Registration Number of Submitter
APR 2 9 2008
Name: CMT Medical Technologies Ltd. (CMT hereafter) Registration: 8030112 Submission contact: Dan Laor Sireni 6, Haifa 32972, Israel TEL: 972-4-8246632
Device Classification
| Product Code: | LLZ |
|---|---|
| Regulation Number: | 892.2050 |
| Common Name: | PACS - Picture archiving &communications system |
| Classification Name: | Picture archiving and communications system |
| Regulatory class: | Class II |
Reason for 510(k) Submission
Special 510(k) Submission
Identification of Legally Marketed Equivalent Devices
K961307 SMARTSPOT
Device Description
The SmartSPOT PrimaX is a high-resolution digital imaging system designed for Digital Spot Imaging. The system is based on a PC Workstation running Windows XT as the operating system. The legally marketed SMARTSPOT K961307 has been modified: To improve its cost effectiveness, aging technologies and components (hardware and software) have been redesigned. The device major functions and principle of operation were not changed.
Indications for use
The SmartSPOT PrimaX enhances the quality of the fluoroscopy image, enables acquisition and display of high quality resolution (1024X1024 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 technique.
Fields of application of the system are: gastrointestinal examinations, interventional procedures, peripheral angiography studies, urology examinations and other routine fluoroscopy studies.
Safety & Effectiveness
The device has been designed verified and validated complying with 21 CFR 820.30 regulations. Tests data demonstrate that the SMARTSPOT PrimaX meets the required specifications. No adverse affects have been detected.
Substantial Equivalency
It is CMT opinion that the SmartSPOT PrimaX is substantially equivalent in terms of safety and effectiveness to the predicate device.
1
Image /page/1/Picture/0 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three wavy lines emanating from its body, representing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 9 2008
CMT Medical Technologies Ltd. c/o Mr. Dan Laor Quasar Quality Ltd. 6 Sireni HAIFA 32972, ISRAEL
Re: K080890
Trade/Device Name: SmartSPOT PrimaX Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communication system Regulatory Class: II Product Code: LLZ Dated: March 27, 2008 Received: March 31, 2008
Dear Mr. Laor:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
2
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known):
k osorqa
SmartSPOT PrimaX Device Name:
Indications For Use: The SmartSPOT PrimaX enhances the quality of the fluoroscopy image, enables acquisition and display of high quality resolution (1024X1024 pixels) radiographic images and gives the user the possibility to perform advanced studies involving image digital subtraction, such as Road mapping and DSA, that were not possible with conventional technique.
Fields of application of the system are: gastrointestinal examinations, interventional procedures, peripheral angiography studies, urology examinations and other routine fluoroscopy studies
Prescription Use: YE (Part 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use: NO (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal a Radiological Devices 510(k) Number
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