(65 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on hardware integration and software redesign without mentioning AI/ML capabilities.
No
This device is a digital radiography system intended for general radiographic examinations, which is used for diagnostic imaging, not for therapeutic purposes.
No
The device is described as a Digital Radiography system used for general radiographic examinations to create images of various anatomical sites. While these images can be used by a physician for diagnosis, the device itself is an imaging device that produces data, rather than a diagnostic device that analyzes data to provide a diagnosis. The provided text does not mention any built-in analytical or interpretative functions for diagnosis.
No
The device description explicitly states it features an integrated portable flat panel digital detector (FPD), which is a hardware component.
Based on the provided information, the PrestoDR Portable is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for "general radiographic examinations" and lists anatomical sites like the skull, chest, spine, etc. This is consistent with medical imaging for diagnosis based on anatomical structure, not analysis of biological samples.
- Device Description: The description details a Digital Radiography system with a flat panel detector, which is a standard component of X-ray imaging systems.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other elements typically associated with in vitro diagnostics.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. The PrestoDR Portable is a medical imaging device used to create images of the inside of the body.
N/A
Intended Use / Indications for Use
The PrestoDR Portable, is intended for use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. PrestoDR Portable allows imaging of the skull, chest, shoulders, spine, abdomen, and extremities.
Product codes
MOB, IZL, MQB
Device Description
The PrestoDR Portable is a Digital Radiography system, featuring an integrated portable flat panel digital detector (FPD) K090625 WIRELESS PORTABLE DETECTOR FD-W17, Philips Medical Systems North America CO (this is the 510(k) for the wireless portable flat panel detector) and CMT's proprietary technology, which incorporates state of the art object-oriented software and connectivity. The legally marketed SMARTRAD K003438 has been modified: To integrate the portable flat panel digital detector (FPD) K090625, 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
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 Portable 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
§ 892.1720 Mobile x-ray system.
(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. 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
510(k) Summary of Safety and Effectivencss (in accordance to 21 CFR 807.87(h))
Device Name
Proprietary Device Name: PrestoDR Portable
Establishment Name and Registration Number of Submitter
APR 2 2 2010
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:+972-4-9590888,
Device Classification
Product Code: MOB 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 K003438 SMARTRAD K090625 WIRELESS PORTABLE DETECTOR FD-W17
Device Description
The PrestoDR Portable is a Digital Radiography system, featuring an integrated portable flat panel digital detector (FPD) K090625 WIRELESS PORTABLE DETECTOR FD-W17, Philips Medical Systems North America CO (this is the 510(k) for the wireless portable flat panel detector) and CMT's proprietary technology, which incorporates state of the art object-oriented software and connectivity. The legally marketed SMARTRAD K003438 has been modified: To integrate the portable flat panel digital detector (FPD) K090625, 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 PrestoDR Portable, is intended for use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. PrestoDR Portable 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 Portable meets the required specifications. No adverse affects have been detected.
Substantial Equivalency
It is CMT opinion that the PrestoDR Portable 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 U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Shlomi Dines Director of Quality & Regulatory Affairs CMT Medical Technologies, Ltd. Hacarmel St., Bld. 7/2. POB. 111 Industrial Park, Yoqneam Ilit 20692 ISRAEL
AUG 2 3 2013
Re: K100400 Trade/Device Name: PrestoIDR Portable Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: IZL and MQB Dated: April 9, 2010 Received: April 13, 2010
Dear Mr. Dines:
This letter corrects our substantially equivalent letter of April 22, 2010.
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
510(k) Number (if known):
Device Name: PrestoDR: Portable
Indications For Use: The PrestoDR Portable ™, is intended for use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. PrestoDR Portable ™ allows imaging of the skull, chest, shoulders, spine, abdomen, and extremities.
Prescription Use: YES (Part 21 CFR 801 Subpart D)
БЮК.
AND/OR
. . .
Over-the-Counter Use: NO (Part 21 CFR B01 Subpart C)
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Concurrence of CDRH; Office of Device Evaluation (ODE)
Robert Bookerf
(Division Sign-Off)
Division of Rediological Dev Office of In Vitro Diagnostic Device Evalu tion and Safety