FLXIS

K050692 · Philips Medical Systems North America Co. · JAA · Apr 8, 2005 · Radiology

Device Facts

• Record ID: K050692
• Device Name: FLXIS
• Applicant: Philips Medical Systems North America Co.
• Product Code: JAA · Radiology
• Decision Date: Apr 8, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2

Indications for Use

FLXIS is intended to visualize anatomical structures by converting a pattern of Xradiation into a visible image through electronic amplification.

Device Story

FLXIS is a family of image detection components for fluoroscopic X-ray systems. Inputs consist of X-ray radiation patterns; device converts these into visible images using image intensifiers, a camera, and image processing functionality. System includes remote control user interface and optional display module. Used in clinical settings by healthcare professionals to visualize anatomical structures. Output is a visible image, facilitating clinical decision-making by providing real-time anatomical visualization. Device complies with DICOM standards for digital imaging communication.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and intended use compared to the predicate device.

Technological Characteristics

Image-intensified fluoroscopic X-ray system components including image intensifiers, camera, image processing, and remote control interface. Complies with 21 CFR Subchapter J (Radiological Health), UL60601-1 safety standards, and ACR/NEMA DICOM standards.

Indications for Use

Indicated for visualization of anatomical structures via conversion of X-ray patterns into visible images using electronic amplification. No specific patient population, age, or gender restrictions provided.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• OmniDiagnost Eleva (K032046)

Submission Summary (Full Text)

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Philips Medical Systems Nederland B.V. Business Group Digital Imaging Systems PMG Common Imaging Subsystems

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#### 2005 APR 8 510(k) Summary

K050692

The following information is being submitted in accordance with the requirements of 21CFR 807.92.

| Company Name: | Philips Medical Systems North America Company |
|-----------------------------------|-------------------------------------------------------------------------------------|
| Address: | 22100 Bothell Everett Highway<br>P.O.Box 3003<br>Bothell, WA 98041-3003, USA |
| Registration No : | 1217116 |
| Contact Person:<br>Telephone No.: | Lynn Harmer<br>[phone] |
| Date Prepared: | March 14, 2005 |
| Device (Trade) Name: | FLXIS |
| Classification Names: | Image intensified fluoroscopic X-ray system<br>21CFR892.1650, Class II (code 90JAA) |

### Predicate Device:

FLXIS is substantially equivalent to the OmniDiagnost Eleva, both manufactured by Philips Medical Systems Nederland B.V. The OmniDiagnost Eleva received a 510(k) substantially equivalent determination in K032046 on July 17th, 2003.

#### Device description:

FLXIS is a family of image detection components including image intensifiers, a camera, an image processing functionality and a remote control user interface, of which several an inage probeconfigured. Each configuration can be delivered with a display module.

#### Intended use:

FLXIS is intended to visualize anatomical structures by converting a pattern of Xradiation into a visible image through electronic amplification.

## General Safety and Effectiveness information:

The device and its labeling will comply with the applicable requirements of:

- Title 21 Code of Federal Regulations, Subchapter J Radiological Health, parts . 1010, 1020.30, 1020.32.
- Underwriters Laboratories standard for Safety UL60601-1 and be classified by ● Underwriters Laboratories (UL).
- ACR/NEMA DICOM digital imaging communication standard. .

#### Conclusion:

FLXIS does not introduce any new indications for use, nor does the use of the device result in any new potential hazard. Philips Medical Systems Nederland B.V. considers FLXIS to be substantially equivalent with the predicate device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 8 2005

Ms. Lynn Harmer Manager, Regulatory Affairs Philips Medical Systems North America 22100 Bothell Everett Highway Post Office Box 3003 98141-3003 BOTHELL WA 98021-8431

Re: K050692 Trade/Device Name: FLXIS Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: JAA Dated: March 15, 2005 Received: March 17, 2005

Dear Ms. Harmer:

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 either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter whit anow you to begin maing of substantial equivalence of your device to a legally premarket notification: "The PDF maing of backing 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 Part 801), please If you desire specific act no re of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, prodoc note the regation on your responsibilities under the Act from the 807.77). Tournaly oount ourers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): _Koso692 Device Name: FLXIS Indications for Use:

FLXIS is intended to visualize anatomical structures by converting a pattern of Xradiation into a visible image through electronic amplification.

Prescription Use yes
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ No (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Brydon

(Division Sign-Off) (Division of Reproductive) Division of Radiological Devices 510(k) Number -

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