EXPEDIO 500D R&F X-RAY SYSTEM

K011624 · GE Medical Systems · JAA · Jun 8, 2001 · Radiology

Device Facts

• Record ID: K011624
• Device Name: EXPEDIO 500D R&F X-RAY SYSTEM
• Applicant: GE Medical Systems
• Product Code: JAA · Radiology
• Decision Date: Jun 8, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Expedio 500D is designed to perform radiographic and fluoroscopic x-ray examinations.

Device Story

Expedio 500D is a stationary radiographic and fluoroscopic X-ray system. Components include X-ray generator, angulating table, X-ray tube, collimator, image intensifier, wall stand, overhead tube suspension, operator console, and digital archive system. Operated by clinical staff in a radiology setting to perform diagnostic X-ray imaging. System captures X-ray signals, processes them for visualization, and archives digital images. Output allows clinicians to perform diagnostic examinations and inform clinical decision-making. Benefits include diagnostic imaging capabilities for patient assessment.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and conformance to established safety standards (21 CFR 1020.30, 1020.31, 1020.32, UL 2601-1, IEC 601-1 series).

Technological Characteristics

Stationary X-ray system. Components: X-ray generator, angulating table, X-ray tube, collimator, image intensifier, wall stand, overhead tube suspension, operator console, digital archive. Conforms to UL 2601-1, IEC 601-1, IEC 601-1-2, IEC 601-1-3. Regulatory Class II, 21 CFR 892.1650.

Indications for Use

Indicated for patients requiring radiographic and fluoroscopic X-ray examinations.

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

• Advantx Radiographic System (K862120)
• InfiMed Patriot (K963037)
• Legacy/Legacy D Table (K973039)

Submission Summary (Full Text)

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K011624

GE Medical Systems P.O. Box 414, W-709 Milwaukee, WI 53201 USA

## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Pat 807.87(h).

| <b>Identification of Submitter:</b> Larry A. Kroger, Ph.D.<br>Senior Regulatory Programs Manager<br>GE Medical Systems<br>Tel. [phone]<br>Summary prepared: 19 February, 2001 |
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| <b>Identification of Product:</b> Expedio 500D Radiographic and Fluoroscopic Imaging System<br><b>Classification Name:</b> Stationary X-ray System<br><b>Manufacturer:</b> GE Medical Systems<br>3000 N. Grandview Blvd.<br>Waukesha, WI 53118 |
| <b>Device Description:</b> The Expedio 500D R&F X-ray System consists of an X-ray<br>generator; angulating table with X-ray Tube, collimator and image<br>intensifier; Wall stand; Overhead tube suspension; Operator<br>Console; and Digital Archive system. |

The Expedio 500D is designed to perform radiographic and Indications for Use: fluoroscopic x-ray examinations.

The Expedio 500D R&F X-ray System is substantially equivalent Comparison with: to the Advantx Radiographic System (Originally cleared as the SCX K862120), InfiMed Patriot (K963037) and the Legacy/Legacy D Table (K973039).

The Expedio 500D R&F X-ray System will conform to applicable Conformance: sections of 21CFR 1020.30, 1020.31, and 1020.32. The system will also conform to UL 2601-1, IEC 601-1, IEC 601-1-2, and IEC 601-1-3.

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## Conclusions:

In the opinion of GE Medical Systems, the Expedio 500D R&F Xray System is substantially equivalent to the presently marketed Advantx Legacy/Legacy D R&F X-ray System (K862120 and K973039) and the InfiMed Patriot Digital System (K963037). The Expedio 500D does not include any new indications for use, nor does use of this device result in any new potential hazards.

K011624

2/2

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## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

GE Medical Systems % Mr. Reiner Krumme

TUV Rheinland of North America, Inc.

Re: K011624

JUN - 8 2001

Expedio 500D R&F X-Ray System Dated: May 22, 2001 Received: May 25, 2001 Regulatory Class: II 21 CFR 892.1650/Procode: 90 JAA

## Dear Mr. Krumme:

12 Commerce Road

NEWTON CT 06470

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours.

Nancy Cbrogdon

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

Enclosure (s)

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Attachment I b

| Page | of |
|---------------------------|---------|
| 510(k) Number (if known): | K011624 |
| Device Name: | |

Indications For Use:
The Expedio 500 A is designed to
perform radiographic and fluoroscopic
X-ray examinations

(see 510(k) Summary of Safety
and Effectiveness, attachment 1 of
submission)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Formal 1-2-96)

David K. Flynn

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

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