GM60A-32S, GM60A-40S

K142492 · Samsung Electronics Co., Ltd. · IZL · Dec 17, 2014 · Radiology

Device Facts

• Record ID: K142492
• Device Name: GM60A-32S, GM60A-40S
• Applicant: Samsung Electronics Co., Ltd.
• Product Code: IZL · Radiology
• Decision Date: Dec 17, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1720
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The GM60A Digital Mobile X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.

Device Story

GM60A is a mobile digital X-ray imaging system; captures radiographic images of human anatomy. System components: high voltage generator, X-ray tube, collimator, detector, dose area product (DAP) meter, barcode scanner. Operation: X-rays transmitted through patient; detector converts X-rays to electrical signals; signals amplified and converted to digital data; processed by software; saved as DICOM files. Used in clinical settings by physicians or technicians. Output: digital radiographic images sent to PACS for radiologist review. Benefits: enables portable diagnostic imaging for patients unable to be moved to stationary X-ray rooms.

Clinical Evidence

Clinical images were obtained per FDA guidance for Solid State X-ray Imaging Devices. Images were evaluated by professional radiologists and found to be equivalent to the predicate device. No specific sensitivity/specificity metrics reported.

Technological Characteristics

Mobile X-ray system; high-frequency generator (32kW/40kW); 40-150kVp range. Detectors: S4335-W/S4343-W (CsI, indirect). Connectivity: Wired/Wireless DICOM. Standards: ES 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-28, IEC 60601-2-54, ISO 14971, 21 CFR 1020.30/31. MTF/DQE tested per IEC 62220-1.

Indications for Use

Indicated for generating radiographic images of human anatomy in adult and pediatric patients. Not for mammographic applications. Use by qualified/trained doctor or technician.

Regulatory Classification

Identification

A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• Sedecal Easy Moving Plus (K090322)
• Samsung XGEO GC80 (K140334)

Submission Summary (Full Text)

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December 17, 2014

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

Samsung Electronics Co., Ltd. % Chulsin Kim Regulatory Affairs Manager 129. Samsung-ro Yeongtong-gu Suwon-si, Gyeonggi-do, 443742 REPUBLIC OF KOREA

Re: K142492

Trade/Device Name: GM60A-32S, GM60A-40S Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: IZL Dated: November 20, 2014 Received: November 24, 2014

Dear Chulsin Kim:

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: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see 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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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/Resourcesfor You/Industry/default.htm. 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 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,

Robert A Ochs

Robert A. Ochs, Ph.D. Acting 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

510(k) Number (if known) K142492

Device Name GM60A-32S, GM60A-40S

Indications for Use (Describe)

The GM60A Digital Mobile X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.

| Type of Use (Select one or both, as applicable) | <span> <span style="padding-right: 20px;"> <span style="vertical-align: middle;"> </span> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> <span style="vertical-align: middle;"> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

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Image /page/3/Picture/1 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white, set against a blue oval background. The font is bold and sans-serif, and the letters are evenly spaced. The oval is tilted slightly upwards from left to right.

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: November 19, 2014
- 2. Submitter
- A. Company Name: SAMSUNG ELECTRONICS Co., Ltd.
- B. Address: 129, Samsung-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do, 443-742, Republic of Korea

### 3. Primary Contact Person

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

#### 4. Secondary Contact Person

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

#### 5. Identification Device

- A. Trade Name: GM60A
- B. Device Name: GM60A-32S, GM60A-40S
- C. Common Name: Digital Diagnostic Mobile X-ray System
- D. Classification Name: Mobile X-ray System
- ய் Product Code: IZL
- F. Regulation: 21 CFR 892.1720

#### 6. Predicate Device

- 6.1 Predicate Device I

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Image /page/4/Picture/1 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold letters. The word is placed inside of a blue, rounded, oval shape.

510(k) Premarket Notification - Traditional

- A. Manufacturer: Sedecal, Inc. SEDECAL SA
- Device Name: Easy Moving Plus, SM-XXHF-YY B.
- C. Classification Name: Mobile X-ray system, Solid State X-Ray Imager(Flat Panel/Digital Imager)
- D. Product Code: IZL
- E. 510(k) Number: K090322
- 510(k) Decision Date: March 17, 2009 ட

### 6.2 Predicate Device II

- Manufacturer: SAMSUNG ELECTRONICS Co., Ltd. G.
- Trade Name: XGEO GC80 H.
- 1. Classification Name: System, X-ray, Stationary
- J. Product Code: KPR
- 510(k) Number: K140334 K.
- L. 510(k) Decision Date: May 28, 2014

### 7. Device Description

The GM60A Digital Mobile X-ray imaging system consists of High voltage generator (HVG), X-ray tube, Collimator, Detector, DAP and Barcode scanner.

This system is used to capture images by transmitting X-ray to a patient's body.

The X-ray passing through a patient's body is sent to the detector and then converted into electrical signals. These signals go through the process of amplification and digital data conversion in the signal process device before being sent to the operation software and saved in DICOM file, a standard for medical imaging. The captured images are sent to the Picture Archiving & Communication System (PACS) server, and can be used for reading images.

#### 8. Intended Use

The GM60A Digital Mobile X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.

- 9. Summary of Technological characteristic of the proposed device compared with the predicate device
The GM60A' system does not have significant changes in materials, energy source or

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Image /page/5/Picture/1 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white, set against a blue oval background. The oval is tilted slightly, giving the logo a dynamic appearance.

510(k) Premarket Notification - Traditional

technological characteristics compared to the predicate device, Easy moving plus(K090322), and the detectors that GM60A uses are same as the one that the predicate device of XGEO GC80(K140334) uses. Comparisons of the following technological characteristics were assessed and the results demonstrate the substantial equivalence to the predicates.

| Specification | Predicate Device I | Proposed Device | Predicate Device II | Discussion |
|---------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Device Name | Sedecal Easy moving plus | GM60A | XGEO GC80 | |
| Manufacturer | Sedecal SA | SAMSUNG ELECTRONICS | SAMSUNG ELECTRONICS | |
| 510(k) Number | K090322 | N/A | K140334 | |
| Appearances | Image: Sedecal Easy moving plus | Image: GM60A | Image: XGEO GC80 | Same |
| Intended Use | Intended for use by a<br>qualified/trained doctor or<br>technician on both adult<br>and pediatric subjects for<br>taking diagnostic<br>radiographic exposures of<br>the skull, spinal column,<br>chest, abdomen,<br>extremities, and other body<br>parts.<br>Applications can be<br>performed with the patient<br>sitting, standing, or lying in<br>the prone or supine | The GM60A Digital Mobile<br>X-ray Imaging System is<br>intended for use in<br>generating radiographic<br>images of human anatomy<br>by a qualified/trained<br>doctor or technician.<br>This device is not intended<br>for mammographic<br>applications. | The XGEO GC80 digital X-<br>ray imaging system is<br>intended for use in<br>generating radiographic<br>images of human anatomy<br>by a qualified/trained<br>doctor or technician. This<br>device is not intended for<br>mammographic<br>applications. | Same |

| Manufacturer Contents | Sedecal Easy moving plus<br>(K090322) | GM60A | XGEO GC80<br>(K140334) | Discussion | |
|-----------------------|---------------------------------------|------------------------------------------------|------------------------|--------------------|--------------------|
| (1)High | Voltage Generator | | | | |
| Type | High Frequency | High Frequency | High Frequency | Same | |
| Max. Power | 20/32/40/50kW | 32kW / 40kW | 80kW | Same as<br>K090322 | |
| Output<br>RANGE | kVp Range | 40 to 150kVp | 40 to 150kVp | 40 to 150kVp | Same |
| | mA Range | 20kW : 10 to 320mA<br>32/40/50kW : 10 to 500mA | 10 to 500mA | 10-1000mA | Same as<br>K090322 |
| | Exposure Time | 1msec-10sec | 1msec-10sec | 1msec-6.3sec | Same or above |

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Image /page/6/Picture/1 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold letters. The background is a blue, rounded rectangle.

510(k) Premarket Notification - Traditional

| Manufacturer Contents | Sedecal<br>Easy moving plus<br>(K090322) | GM60A | XGEO GC80<br>(K140334) | Discussion | |
|-----------------------|------------------------------------------|-------------------------------|-------------------------------|------------------------|--------------------|
| (2)Tube assembly | | | | | |
| Moving<br>Range | Horizontal | 700~1250 | 700~1250 | 1030~3030 | Same as<br>K090322 |
| | Vertical | 550~2020<br>550~1890 (Option) | 550~2020<br>550~1890 (Option) | $\triangle$ 1,840 | Same as<br>K090322 |
| Rotation<br>Range | Column | $\pm$ 315° | $\pm$ 315° | -157° ~ +183° | Same or better |
| | Tube(Arm axis) | $\pm$ 180° | $\pm$ 180° | $\pm$ 120° | Same or better |
| | Tube(Tube axis) | -30°~90° | -30°~90° | N/A | Same or better |
| Collimator | | RALCO R221 DHHS | RALCO R221 DHHS | SAMSUNG<br>Electronics | Same as<br>K090322 |

| Manufacturer<br>Contents | Sedecal<br>Easy moving<br>Plus(K090322) | GM60A | XGEO GC80 (K140334) | Discussion | | |
|-------------------------------------------------|-----------------------------------------|--------------------------|--------------------------|--------------------------|------------------------------|----------------|
| (3) Detectors | | | | | | |
| Name | Canon<br>CXDI-50G | S4335-W | S4343-W | S4335-W | S4343-W | |
| | GOS | Csl | Csl | Csl | Csl | Same or better |
| Detector Type | Indirect | Indirect | Indirect | Indirect | Indirect | Same |
| Detector Area | 14"X17"<br>(353mmX430mm) | 14"X17"<br>(345mmX425mm) | 17"X17"<br>(425mmX425mm) | 14"X17"<br>(345mmX425mm) | 17"X17"<br>(425mmX425mm<br>) | Similar |
| Number of pixels | 2208X2688 | 2466X3040 | 3036X3040 | 2466X3040 | 3036X3040 | |
| Pixel Pitch(um) | 160 | 140 | 140 | 140 | 140 | Same or better |
| High Contrast<br>Limiting Resolution<br>(LP/mm) | N/A | 3.57 | 3.57 | 3.57 | 3.57 | Same or better |
| Communication | Wired | Wired /<br>Wireless | Wired /<br>Wireless | Wired /<br>Wireless | Wired /<br>Wireless | Same or better |
| (4) Grid | | | | | | |
| Lines/cm | 40 | 84.6 | 84.6 | | Same or better | |
| Grid mechanism | Stationary | Stationary | Stationary | | Same | |
| Removability | Removable | Removable | Removable | | Same | |

### 10. Safety, EMC and Performance Data

Electrical, mechanical, environmental safety and performance testing according to standard ES 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-28, IEC 60601-2-54, ISO14971, 21CFR1020.30 and 21CFR1020.31 were performed, and EMC testing was

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Image /page/7/Picture/1 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white, set against a blue, oval-shaped background. The font is sans-serif and bold, and the oval is tilted slightly upwards from left to right.

510(k) Premarket Notification - Traditional

conducted in accordance with standard IEC 60601-1-2:2007. Wireless function was tested and verified followed by guidance, Radio frequency Wireless Technology in Medical Devices. All test results were satisfied.

#### 11. Non-clinical data

In non-clinical data, MTF and DQE were tested and measured by IEC 62220-1. The proposed device shows same curves and measurements of MTF and DQE than the predicate device (K140334) at all spatial frequencies tested.

### 12. Clinical data

In clinical data, clinical images were obtained in accordance with FDA guidance for the submission of 510(k)'s for Solid State X-ray Imaging Devices. They were evaluated by professional radiologists and found to be equivalent to the predicate device.

### 13. Conclusions

The non-clinical and clinical data that demonstrate that the device is as safe, as effective, and performs as well as or better than the leqally marketed device identified in paragraph 6, above.

- 14. Samsung Electronics Co., Ltd. will update and include in this summary any other information deemed seasonably necessary by the FDA