XGEO GR40CW

K140235 · Samsung Electronics Co., Ltd. · MQB · May 15, 2014 · Radiology

Device Facts

• Record ID: K140235
• Device Name: XGEO GR40CW
• Applicant: Samsung Electronics Co., Ltd.
• Product Code: MQB · Radiology
• Decision Date: May 15, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

The XGEO GR40CW Digital X-ray Imaging System is intended for use in general projection radiographic applications wherever conventional screen-film systems may be used. This device is not intended for mammographic applications.

Device Story

XGEO GR40CW is a stationary digital X-ray imaging system; utilizes flat panel detector technology to capture radiographic images; intended for general projection radiography; excludes mammography. System operated by trained healthcare professionals in clinical settings. Device transforms X-ray radiation into digital image data for display and diagnostic review by clinicians. Facilitates clinical decision-making through high-resolution digital imaging; replaces conventional screen-film systems.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and technological comparison to the predicate device.

Technological Characteristics

Stationary digital X-ray system; utilizes solid-state flat panel detector for image acquisition. System is designed for general radiographic applications. Connectivity via standard digital imaging interfaces. Regulatory class II; product code MQB.

Indications for Use

Indicated for general projection radiographic applications in patients requiring diagnostic imaging, excluding mammography.

Regulatory Classification

Identification

A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. 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). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary 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.

Predicate Devices

• XGEO GC80 (K123098)

Submission Summary (Full Text)

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**MAY 15 2014** K140235

# SAMSUNG ELECTRONICS Co., Ltd.

510(k) Premarket Notification - Traditional

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted accordance with requirements of 21 CFR 807.92

- 1. Date: Jan. 29, 2013
- 2. Submitter
- A. · Company Name: SAMSUNG ELECTRONICS Co., Ltd.
- Address: 129, Samsung-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do, 443-742, B. Republic of Korea

#### Primary Contact Person 3.

- Name: Donald D. Fickett A.
- Title: Vice President Regulatory & Quality Assurance B.
- Phone Number: 978-564-8523 ﻥ
- FAX Number: 978-750-6677 D.
- E. E-Mail: [e-mail]

#### Secondary Contact Person 4.

- A. Name: Ha, Aeyoung
- B. Title: Regulatory Affairs Manager
- C. Phone Number: [phone]
- FAX Number: [phone] D.
- E. E-Mail: [e-mail]

#### 5. Device

- A. Trade Name: XGEO GR40CW
- Common Name: Stationary x-ray System B.
- ். Classification Name: Solid state x-ray imager (flat panel/digital imager)
- D. Product Code: MQB

#### Predicate Device 6.

- Manufacturer: SAMSUNG ELECTRONICS Co., Ltd. A.
- B. Trade Name: XGEO GC80
- C. 510(k) Number: K123098

### VI - 2

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Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol of medicine. The caduceus has three lines representing the snakes and a staff in the center.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 15, 2014

SAMSUNG ELECTRONICS Co., Ltd. % Jeongpyo Hong Assistant Manager. Regulatory Affairs 129, Samsung-ro, Yeongtong-gu Suwon-si, Gyeonggi-do, 443-742 REPUBLIC OF KOREA

Re: K140235

Trade/Device Name: XGEO GR40CW Regulation Number: 21 CFR 872.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: April 15, 2014 Received: April 16, 2014

Dear Jeongpyo Hong:

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. Please note: CDRFI does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not mislcading.

If your device is classified (sec above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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Page 2-Jeongpyo Hong

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Smh.7)

for

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K140235

Device Name XGEO GR40CW

### Indications for Use (Describe)

The XGEO GR40CW Digital X-ray Imaging System is intended for use in general projection radiographic applications wherever conventional screen-film systems may be used. This device is not intended for mammographic applications.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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