(29 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on hardware and software redesign for cost-effectiveness and aging components, not AI/ML capabilities.
No.
The device is described as a Digital Radiography system intended for general radiographic examinations, which is a diagnostic imaging procedure, not a therapeutic one.
Yes
The device is a Digital Radiography system used for general radiographic examinations to image various anatomical sites. Radiographic examinations are a form of medical imaging primarily used to diagnose conditions by visualizing internal structures of the body.
No
The device description explicitly states it features an "integrated flat panel digital detector (FPD)" and mentions redesigning "aging technologies and components (hardware and software)". This indicates the device includes significant hardware components beyond just software.
Based on the provided information, the PrestoDR 4143 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states it's for "general radiographic examinations" and imaging of various anatomical sites using X-ray. This is a diagnostic imaging device, not a device used to examine specimens derived from the human body (like blood, urine, tissue, etc.) outside of the body.
- Device Description: The description confirms it's a "Digital Radiography system" featuring a flat panel detector and software for capturing X-ray images.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with IVD devices.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health status. The PrestoDR 4143 is used to create images of the internal structures of the body using X-rays.
N/A
Intended Use / Indications for Use
The PrestoDR 4143, is intended for use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. PrestoDR 4143 allows imaging of the skull, chest, shoulders, spine, abdomen, and extremities.
Product codes
MQB, KPR
Device Description
The PrestoDR 4143 is a Digital Radiography system, featuring an integrated flat panel digital detector (FPD) and CMT's proprietary technology, which incorporates state of the art objectoriented software and connectivity. The legally marketed PrestoDR Portable K 100400 has been modified: To integrate the Pixium 4143 flat panel digital detector (FPD), improve its cost effectiveness, aging technologies and components (hardware and software) have been redesigned. The device major functions, intended use and principle of operation were not changed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
skull, chest, shoulders, spine, abdomen, and extremities
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)
The device has been designed verified and validated complying with 21CFR 820.30 regulations. Tests data demonstrate that the PrestoDR 4143 meets the required specifications. No adverse affects have been detected.
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
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
510(k) Summary of Safety and Effectiveness (is accordance to 21 CFR 807.97(0))
APR 2 6 2011
Device Name
Proprietary Device Name: PrestoDR 4143
Establishment Name and Registration Number of Submitter
Name: CMT Medical Technologies Ltd. Registration: 8030112 Submission contact: Shlomi Dines Hacarmel St. Bld 7/2, POB. 111, Industrial Park, Yoqneam Ilit 20692, ISRAEL, Tel:+972-4-8566220 +972-52-4854411, Fax:+972-3-5212202,
Device Classification
| Product Code: | MQB |
|---|---|
| Regulation Number: | 892.1650 |
| Common Name: | Solid state X-Ray imager |
| Classification Name: | Image intensified fluoroscopic x-ray system |
| Regulatory class: | Class II |
Reason for 510(k) Submission Special 510(k) Submission
Identification of Legally Marketed Equivalent Devices K100400 PrestoDR 4143
Device Description
The PrestoDR 4143 is a Digital Radiography system, featuring an integrated flat panel digital detector (FPD) and CMT's proprietary technology, which incorporates state of the art objectoriented software and connectivity. The legally marketed PrestoDR Portable K 100400 has been modified: To integrate the Pixium 4143 flat panel digital detector (FPD), improve its cost effectiveness, aging technologies and components (hardware and software) have been redesigned. The device major functions, intended use and principle of operation were not changed.
Indications for use
The PrestoDR 4143, is intended for use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. PrestoDR 4143 allows imaging of the skull, chest, shoulders, spine, abdomen, and extremities.
Safety & Effectiveness
The device has been designed verified and validated complying with 21CFR 820.30 regulations. Tests data demonstrate that the PrestoDR 4143 meets the required specifications. No adverse affects have been detected.
Substantial Equivalency
It is CMT opinion that the PrestoDR 4143 is substantially equivalent in terms of safety and effectiveness to the predicate device.
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Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a stylized human figure in blue, along with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in blue font. The text is positioned to the right of the human figure.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Ms. Shlomi Dines Director of Quality and Regulatory Affairs CMT Medical Technologies, Ltd. Hacanean St. 7/2, PO Box 111 Industrial Park YORKNEAM ILIT 20692 ISREAL
AUG 2 0 2013
Trade/Device Name: PrestoDR 4143 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray System Regulatory Class: II Product Code: KPR Dated: March 1. 2011 Received: March 28. 2011
Dear Ms. Dines:
Re: K110849
This letter corrects our substantially equivalent letter of April 26, 2011.
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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 Parts 801 and 809); medical device reporting (reporting of
2
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
Device Name: PrestoDR 4143
510(k) Number (if known):
Indications For Use: The PrestoDR 4143 ™, is intended for use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. PrestoDR 4143 ™ allows imaging of the skull, chest, shoulders, spine, abdomen, and extremities.
Prescription Use: YES (Part 21 CFR 801 Subpart D)
AND/OR
10K-
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 Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
| 510K | K110849 |
|---|---|
| ------ | --------- |
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