(15 days)
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Not Found
No
The summary does not mention AI, ML, or related terms, nor does it describe features typically associated with AI/ML in medical imaging (like automated detection, segmentation, or analysis).
No
The device is described as an X-ray system intended for diagnostic imaging procedures (radiography, fluoroscopy, interventional, and angiography), not for treating conditions.
Yes
The device is used for performing radiography, fluoroscopy, interventional, and angiography procedures/applications, which are methods of imaging the body to diagnose medical conditions.
No
The intended use clearly describes an "Analog X-ray System and PRECISION RXi Digital X-ray System," which are hardware-based medical devices. The summary does not mention any software-only component or function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the system is for performing general R&F, radiography, fluoroscopy, interventional, and angiography procedures/applications. These are all procedures performed on a patient using imaging, not tests performed on samples taken from a patient (which is the definition of an in vitro diagnostic).
- Lack of IVD Indicators: There is no mention of analyzing biological samples, reagents, or any other typical components of an IVD.
Therefore, the PRECISION RXi Analog X-ray System and PRECISION RXi Digital X-ray System are medical imaging devices, not IVDs.
N/A
Intended Use / Indications for Use
The PRECISION RXi Analog X-ray System and PRECISION RXi Digital X-ray System are intended for performing general R&F, radiography, fluoroscopy, interventional and angiography procedures/applications.
Product codes
OWB, JAA
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle with three heads.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
General Medical Merate S.P.A. % Mr. Tamas Borsai Program Manager TUV Rheinland of North America 12 Commerce Road NEWTIWN CT 06470
FEB 1 9 2013
Re: K041605
Trade/Device Name: PRECISION RXi Analog X-ray System and PRECISION RXi Digital X-ray System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB and JAA Dated: June 8, 2004 Received: June 15, 2004
Dear Mr. Borsai:
This letter corrects our substantially equivalent letter of June 30, 2004.
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 of
1
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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Page 1 of 1 0416
510(k) Number (if known):
PRECISION RXi Analog X-ray System Device Name: PRECISION RXi Digital X-ray System
Indications for Use: The PRECISION RXi Analog X-ray System and PRECISION RXi Thurcations for 030. This Finated for perfoming general R&F, radiography, fluoroscopy, interventional and angiography procedures/applications.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Tomith. Lyson
(Division Sign-Off) Division of Reproductive, Abdomina Radiological Devices 510(k) Number
Prescription Use × (Per 21 CFR 801.109)