PHILIPS MULTIDIAGNOST 4 by PHILIPS MEDICAL SYSTEMS, INC.

The provided document is a 510(k) summary for the Philips MultiDIAGNOST 4, Universal Tilt C-Arm System, primarily focusing on its substantial equivalence to predicate devices and regulatory compliance. It does not contain any information regarding acceptance criteria, device performance metrics, or study details such as sample sizes, ground truth establishment, or expert qualifications in the way typically required for AI/ML-driven medical devices.

Therefore, I cannot provide the requested table and study details. The document is a regulatory approval document for a traditional X-ray system, not an AI/ML device, and thus does not include the type of performance evaluation data you are asking for.

Summary

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Image /page/0/Picture/0 description: The image shows the word "PHILIPS" in bold, black letters. To the left of the word is the Philips logo. Below the word "PHILIPS" is the number "K96/374" in a handwritten style.

Philips Medical Systems

P.O. Box 10000, 5680 DA Best, The Netherlands

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Department of Health and Human Services Center for Devices and Radiological Health Office of Device Evaluation Pre-Market Notification section

Qual. Ass. Dpt. XSB/XCB XB030-960317/RR/gd

1996.03.01

SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

for

PHILIPS MULTI DIAGNOST 4, UNIVERSAL TILT C-ARM SYSTEM

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

The undersigned certifies that the 510(k) Pre-Market notification for the above referenced I he undersigned cellules that the 910(x) 110 Market would CDRH to determine substantial equivalence.

This information and data is summarized as follows:

The Multi Diagnost 4 system subject to Federal Performance Standards, defined in 1. 21 CFR - part 1000;
The Multi Diagnost 4 system will be manufactured in accordance with voluntary safety 2. standards, such as UL 187;
The information for Users contains comprehensive information to insure safe and 3. effective use;
Past experience with substantially equivalent predicate devices has shown our device to 4. Fast experience with based as directed in the Information for Users.

Ing. R. W. Rijntjes
Approbation officer

Quality Assurance dept. XSB / XCB Philips Medical Systems Nederland BV Best, The Netherlands.

:04 :00 :

527

Philips Medical Systems Neder 12 Veerpluis 6, Best, The Nether ... . Tel: + 31 40 27 911 11 Fax: +31 40 27 622 05 Commercial Register Eindho ...

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

Mr. Peter Altman Director of Regulatory Affairs Philips Medical Systems, Inc. North America Company 710 Bridgeport Avenue SHELTON CT 06484

FEB 1 9 2013

Re: K961374

Trade/Device Name: PHILIPS MultiDIAGNOST 4 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB and JAA Dated: May 22, 1996 Received: May 23, 1996

Dear Mr. Altman:

This letter corrects our substantially equivalent letter of August 19, 1996.

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection 910(t) presidentially 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 commence province in May 20, 1978, the encordance with the provisions of the Federal Food, DNIg, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). alla Costience Act (Act) that do not require to the general controls provisions of the Act. The I ou may, mercedes, manot the Act include requirements for annual registration, listing of general controls provisions of ractice, 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 IT your device is elassified (coo aoor 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 Please be advised that I DA 3 issuated of a buccession of the requirements of the Act that IDA has made a determination administered by other Federal agencies. You must or ally it ederal statutes and regulations and limited to: registration and listing (21 comply with an the Act 3 requirements, moraling, or, 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/industrv/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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510(k) Number (if known):

Unknown

Device Name :

Philips MultiDIAGNOST 4

Indications For Use :

The MultiDIAGNOST 4 is indicated for use in Radiographic/Fluoroscopic, Angiographic, and Interventional diagnostic imaging examinations.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ylurid le. Siyom

(Division Sign-Off) (Division of Reproductive, Abdominal, ENT, and Radiological Devics Q61374 510(k) Number

Prescription Use
( Per 21 CFR 801.109

Over-The-Counter Use

(Optional Formal 1-2-4-1

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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.