The GE Precision MPi is an all-digital multipurpose tilt-C X-ray system, intended for a multitude of diagnostic procedures, including: R&F, radiology, fluoroscopy, interventional procedures, vascular and non-vascular procedures, and specialized applications including angiographic studies.

The GE Precision MPi is a multi-purpose system that can perform general R&F, radiography, fluoroscopy, interventional and angiography procedures/applications.

Device Description

The GE Precision MPi tilt-C consists of an X-ray Generator, Right or Left side suspended Angulations Table with X-ray Tube, Collimator and Image Intensifier, Operators console, and Digital Imaging/Archive system.

AI/ML Overview

The provided text does not contain any information about acceptance criteria or a study proving device performance in the context of AI/ML or diagnostic accuracy studies.

This document is a 510(k) premarket notification for a medical device called the "GE Precision MPi Universal tilt-C." It's a traditional medical device (an X-ray system), not an AI/ML powered device.

The information primarily focuses on:

Device Description: An X-ray Generator, Angulations Table with X-ray Tube, Collimator and Image Intensifier, Operators console, and Digital Imaging/Archive system.
Intended Use: R&F, radiology, fluoroscopy, interventional procedures, vascular and non-vascular procedures, and specialized applications including angiographic studies.
Technological Differences: States there are no technological differences between the GE Precision MPi and its predicate device (Philips MultiDiagnost 4, K961374).
Conformance: Adherence to relevant sections of 21CFR (1020.30, 1020.31, 1020.32) and standards like UL60601-1, IEC60601-1.
Conclusion: Substantial equivalence to the predicate device.

Therefore, I cannot provide the requested table or answer the questions related to AI/ML device performance, sample sizes for test/training sets, ground truth establishment, or expert adjudication, as this information is not present in the given text.

Summary

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NOV 1 9 2003

Image /page/0/Picture/1 description: The image shows a logo with the letters "NRT" in a rounded rectangle at the top. Below that is the text "NORDISK RØNTGEN TEKNI" in a black rounded rectangle. At the bottom of the image is the text "Ko 33486" in a handwritten style.

510(K) Summary of Safety and Effectiveness As required by section 807.92

Date Prepared: October 3, 2003 Applicant: NRT - Nordisk Roentgen Teknik A/S Quality Assurance Specialist Jan Malling Birkegaardsvej 16 Address: DK-8361 Hasselager DENMARK Contact: Tel.no. +45 8628 3500 Fax no. +45 8628 3088 Email: nrt@nrtxray.com Device name: GE Precision MPi Universal tilt-C Common name: Class II, sec.21CFR892.1650, Radiology, Image-intensified Classification: fluoroscopic x-ray system JAA, DWB Product code:

Legally marketed device to which we claim equivalence: Philips MultiDiagnost 4, 510(K) no. K961374.

Device Description:

Intended Use:

Summary of technological differences

There are no technological differences between the GE Precision MPi and The MultiDiagnost 4. Many of the components used are currently available and have been chosen for the GE Precision MPi to ensure proven effectiveness and safety.

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Conformance:

The GE Precision MPi will conform to the applicable sections of 21CFR 1020.30, 1020.31, and 1020.32. The system will also conform to UL60601-1, IEC60601-1 and applicable collateral and particular standards.

Conclusion:

We believe that the GE Precision MPi is substantially equivalent to the Philips MultiDiagnost 4. The GE Precision MPi and the Philips MultiDiagnost 4 is intended for the same type of clinical use and for the same group of users. The GE Precision MPi does not introduce any new potential hazards.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is composed of three thick, curved lines that form the shape of the bird's body and wings. The text is in a simple, sans-serif font and is evenly spaced around the circle.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

NRT-Nordisk Roentgen Teknik A/S % Mr. Heinz-Jörg Steneberg Division Manager, Medical Division TUV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470

MAY - 7 2012

Re: K033486

Trade/Device Name: GE Precision MPi Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB and JAA Dated: October 31, 2003 Received: November 4, 2003

Dear Mr. Steneberg:

This letter corrects our substantially equivalent letter of November 19, 2003.

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

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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

KO33486 510(k) Number (if known):

PRECISION MI Device Name: GE

Indications For Use:

The GE Precision MPi is a multi-purpose system that can perform general R&F, radiography, fluoroscopy, interventional and angiography procedures/applications.

Prescription Use
(Part 21 CFR 801 Subpart D) /

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Hogdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K033486

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Regulation Number and Section

§ 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.