GM60A-32S, GM60A-40S

• K Number: K142492
• Device Name: GM60A-32S, GM60A-40S
• Manufacturer: SAMSUNG ELECTRONICS CO., LTD.
• Date Cleared: 2014-12-17 ( 104 days)
• Product Code: IZL KPR
• Regulation Number: 892.1720

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 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.

Predicate Devices

K090322, K140334

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes standard digital X-ray imaging system components and processes, with no mention of AI, ML, or related concepts in the device description, performance studies, or key metrics.

Therapeutic

No
This device is an imaging system used to generate radiographic images for diagnostic purposes, not for treating any condition.

Diagnostic

Yes

The device generates radiographic images of human anatomy for reading by qualified/trained doctors or technicians, which are used to aid in diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly lists multiple hardware components (High voltage generator, X-ray tube, Collimator, Detector, DAP, Barcode scanner) and describes a system that captures images using X-rays, which is a hardware-dependent process. The software mentioned is part of a larger hardware system.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body. They perform tests in vitro (in glass or in a lab setting) to diagnose or monitor conditions.
• This device is an X-ray imaging system. It generates images of the human anatomy in vivo (within the living body) by transmitting X-rays through the patient.

The description clearly states its purpose is to generate radiographic images of human anatomy, which is a form of medical imaging, not in vitro diagnostic testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes

IZL

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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

X-ray

Anatomical Site

human anatomy

Indicated Patient Age Range

Not Found

Intended User / Care Setting

qualified/trained doctor or technician

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.
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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K090322, K140334

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 892.1720 Mobile x-ray system.

(a)
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.(b)
Classification. Class II.

Summary

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

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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
qualified/trained doctor or
technician on both adult
and pediatric subjects for
taking diagnostic
radiographic exposures of
the skull, spinal column,
chest, abdomen,
extremities, and other body
parts.
Applications can be
performed with the patient
sitting, standing, or lying in
the prone or supine	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.	The XGEO GC80 digital 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.	Same

| Manufacturer Contents | Sedecal Easy moving plus
(K090322) | GM60A | XGEO GC80
(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
K090322 | |
| Output
RANGE | kVp Range | 40 to 150kVp | 40 to 150kVp | 40 to 150kVp | Same |
| | mA Range | 20kW : 10 to 320mA
32/40/50kW : 10 to 500mA | 10 to 500mA | 10-1000mA | Same as
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
Easy moving plus
(K090322) | GM60A | XGEO GC80
(K140334) | Discussion | |
|-----------------------|------------------------------------------|-------------------------------|-------------------------------|------------------------|--------------------|
| (2)Tube assembly | | | | | |
| Moving
Range | Horizontal | 7001250 | 7001250 | 10303030 | Same as
K090322 |
| | Vertical | 5502020
5501890 (Option) | 5502020
550~1890 (Option) | $\triangle$ 1,840 | Same as
K090322 |
| Rotation
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
Electronics | Same as
K090322 |

| Manufacturer
Contents | Sedecal
Easy moving
Plus(K090322) | GM60A | XGEO GC80 (K140334) | Discussion | | |
|-------------------------------------------------|-----------------------------------------|--------------------------|--------------------------|--------------------------|------------------------------|----------------|
| (3) Detectors | | | | | | |
| Name | Canon
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"
(353mmX430mm) | 14"X17"
(345mmX425mm) | 17"X17"
(425mmX425mm) | 14"X17"
(345mmX425mm) | 17"X17"
(425mmX425mm
) | Similar |
| Number of pixels | 2208X2688 | 2466X3040 | 3036X3040 | 2466X3040 | 3036X3040 | |
| Pixel Pitch(um) | 160 | 140 | 140 | 140 | 140 | Same or better |
| High Contrast
Limiting Resolution
(LP/mm) | N/A | 3.57 | 3.57 | 3.57 | 3.57 | Same or better |
| Communication | Wired | Wired /
Wireless | Wired /
Wireless | Wired /
Wireless | Wired /
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