Digital Diagnostic X-ray System (GC80)

K143029 · Samsung Electronics Co., Ltd. · KPR · Feb 4, 2015 · Radiology

Device Facts

• Record ID: K143029
• Device Name: Digital Diagnostic X-ray System (GC80)
• Applicant: Samsung Electronics Co., Ltd.
• Product Code: KPR · Radiology
• Decision Date: Feb 4, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

The 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.

Device Story

GC80 is a stationary digital X-ray system; captures radiographic images of human anatomy. System components: high voltage generator, ceiling suspension, X-ray tube, collimator, detector, AEC, DAP, control interface, wall stand, patient table, remote controller, grid, foot switch, barcode scanner, auto-stitching stand. X-rays pass through patient; detector converts radiation to electrical signals; signals amplified and digitized; processed by S-Station software; saved as DICOM files; transmitted to PACS for clinical review. Operated by physicians or technicians in clinical settings. Output images assist in diagnostic decision-making. Benefits include high-quality digital imaging for anatomical assessment.

Clinical Evidence

Bench testing performed per IEC 60601-1, 60601-1-2, 60601-1-3, 60601-2-28, 60601-2-54, ISO 14971, and 21 CFR 1020.30/31. Non-clinical performance verified via MTF and DQE measurements per IEC 62220-1, showing no difference from predicate. Clinical images provided to demonstrate system functionality; not required for substantial equivalence determination.

Technological Characteristics

Stationary digital X-ray system. High-frequency generator (max 80kW, 40-150kV). Indirect Csl detectors (14"x17", 17"x17", 10"x12"). Pixel pitch 140um. Motorized ceiling suspension and wall stand. Electromagnetic braking. LED collimator light. DICOM connectivity. Software-based image processing (S-Station).

Indications for Use

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

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 (K140334)

Submission Summary (Full Text)

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

February 9, 2015

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

Re: K143029

Trade/Device Name: Digital Diagnostic X-ray System (GC80) Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: January 6, 2015 Received: January 8, 2015

Dear Chulsin Kim:

This letter corrects our substantially equivalent letter of February 4, 2015.

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

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forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 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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# Indications for Use

510(k) Number (if known) K143029

Device Name GC80

Indications for Use (Describe)

The GC80 Series 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.

Type of Use (Select one or both, as applicable)X 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: January 6, 2015
- 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: GC80
- B. Device Name: GC80
- C. Common Name: Digital Diagnostic X-ray System
- Classification Name: System, X-ray, Stationary D.
- ட். Product Code: KPR
- F. Regulation: 21 CFR 892.1680

#### Predicate Device 6.

- Manufacturer: SAMSUNG ELECTRONICS Co., Ltd. A.

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Image /page/4/Picture/1 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold, sans-serif font. The word is placed on a blue, oval-shaped background.

510(k) Premarket Notification - Traditional

- Trade Name: XGEO GC80 B.
- ட். Classification Name: System, X-ray, Stationary
- D. Product Code: KPR
- டப் 510(k) Number: K140334
- 510(k) Decision Date: May 28, 2014 F.

# 7. Device Description

The GC80 digital X-ray imaging system consists of High voltage generator (HVG), Ceiling Suspension, X-ray tube, Collimator, Detector, AEC, DAP, CIB(Control Interface Box), Wall Stand, Patient Table, Collimator, Detector, Remote controller, Grid, Foot switch, Barcode scanner and Auto-stitching stand.

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 being sent to the S-Station (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 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.

# 9. Summary of Technological characteristic of the proposed device compared with the predicate device

The GC80 adds new detectors to the predicate device, and it does not have significant change in materials, energy source or technological characteristics compared to the predicate device, XGEO GC80 (K140334). Comparisons of the following technological characteristics were assessed and the results demonstrate the substantial equivalence to the predicates.

| Specification | Predicate Device | Proposed Device | Discussion |
|---------------|---------------------|---------------------|------------|
| Device Name | XGEO GC80 | GC80 | |
| Manufacturer | SAMSUNG ELECTRONICS | SAMSUNG ELECTRONICS | |

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Image /page/5/Picture/1 description: The image shows the SAMSUNG logo. The logo is in a blue oval shape. The word "SAMSUNG" is written in white letters inside the oval.

510(k) Premarket Notification - Traditional

| 510(k) Number | K140334 | N/A | |
|---------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Appearances | | | Same |
| Intended Use | 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 doctor<br>or technician. This device is<br>not intended for<br>mammographic applications. | The GC80 digital X-ray<br>imaging system is intended<br>for use in generating<br>radiographic images of<br>human anatomy by a<br>qualified/trained doctor or<br>technician. This device is not<br>intended for mammographic<br>applications. | Same |

| Manufacturer Contents | XGEO GC80<br>(K140334) | GC80 | Discussion | |
|----------------------------------------------|------------------------|----------------|--------------|------|
| (1)High Voltage Generator | | | | |
| Type | High Frequency | High Frequency | Same | |
| Max. Power | 80kW | 80kW | Same | |
| Output<br>RANGE | Tube Voltage | 40-150kV | 40-150kV | Same |
| | Tube Current | 10-1000mA | 10-1000mA | Same |
| | Exposure Time | 1msec-6.3sec | 1msec-6.3sec | Same |
| AEC<br>(Automatic Exposure Control) | Yes | Yes | Same | |
| APR (Anatomically<br>Programmed Radiography) | Yes | Yes | Same | |

| Manufacturer Contents | XGEO GC80<br>(K140334) | GC80 | Discussion | |
|-------------------------|------------------------|-----------------------------------------|-----------------------------------------|------|
| (2)Ceiling Suspension | | | | |
| Moving<br>Range<br>(mm) | Longitudinal | 1680~4180<br>(Varies with room<br>size) | 1680~4180<br>(Varies with room<br>size) | Same |
| | Lateral | 1030~3030<br>(Varies with room<br>size) | 1030~3030<br>(Varies with room<br>size) | Same |

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Image /page/6/Picture/1 description: The image shows the Samsung logo. The logo is in a blue oval shape. The word "SAMSUNG" is written in white letters inside the oval.

510(k) Premarket Notification - Traditional

| Manufacturer Contents | | XGEO GC80<br>(K140334) | GC80 | Discussion |
|-----------------------------|------------|--------------------------|--------------------------|------------|
| | Vertical | 1840 | 1840 | Same |
| Vertical Tube Moving method | | Motorized | Motorized | Same |
| Tube Assembly Rotation | | $-157 ~ +183$ | $-157 ~ +183$ | Same |
| Brake locking Method | | Electromagnetic | Electromagnetic | Same |
| Automatic Centering | | O | O | Same |
| Moving Rail Type | | Al Extrusion | Al Extrusion | Same |
| Image Preview | | O | O | Same |
| Display Type | | Color LCD | Color LCD | Same |
| Control Switch Type | | Button<br>+ Touch Screen | Button<br>+ Touch Screen | Same |
| Vertical Sync. | With Table | O | O | Same |
| | With Stand | O | O | Same |

| Manufacturer Contents | | | XGEO GC80<br>(K140334) | GC80 | Discussion |
|------------------------------|----------------------|-------------------|-------------------------------------------|-------------------------------------------|------------|
| (3) Wall Stand | | | | | |
| | Vertical<br>Movement | Mechanism | Motorized/<br>Manual | Motorized/<br>Manual | Same |
| | | Range(mm) | 400~1800 | 400~1800 | Same |
| Detector/tube servo coupling | | | Yes | Yes | Same |
| Detecto<br>r | Tilting | Mechanism | Motorized | Manual | Same |
| | | Range | -20~+90 | -20~+90 | Same |
| AEC | | | Conventional | Conventional | Same |
| Grid | | Lines/cm | 84.6 | 84.6 | Same |
| | | Grid<br>mechanism | Stationary | Stationary | Same |
| | | | | | |
| | | Removability | Removable | Removable | Same |
| Detector Support Mounting | | | Floor | Floor | Same |
| Patient Support Device | | | Patient handgrips,<br>lateral support bar | Patient handgrips,<br>lateral support bar | Same |

| Manufacturer Contents | XGEO GC80<br>(K140334) | GC80 | Discussion | |
|-----------------------|------------------------|------------|------------|------|
| (4)Patient Table | | | | |
| Table Top | Size(mm) | 2410 X 812 | 2410 X 812 | Same |

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Image /page/7/Picture/1 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold letters. The background is a blue oval shape.

510(k) Premarket Notification - Traditional

| | Manufacturer Contents | | XGEO GC80<br>(K140334) | GC80 | Discussion |
|----------------------------------|-----------------------|-------------------------|------------------------------|------------------------------|------------|
| | Range<br>e<br>(mm) | Lateral<br>Longitudinal | ±140<br>±480 | ±140<br>±480 | Same |
| Table<br>height | Mechanism | | DC Motor, Ball screw | DC Motor, Ball screw | Same |
| | Range(mm) | | 545 ~ 900 | 545 ~ 900 | Same |
| Horizontal range of detector(mm) | | | 590 | 590 | Same |
| AEC | | | Conventional | Conventional | Same |
| | Lines/cm | | 84.6 | 84.6 | Same |
| Grid | Grid mechanism | | Stationary | Stationary | Same |
| | Removability | | Removable | Removable | Same |
| Vertical Sync. | | | O | O | Same |
| | Control Switch Type | | Foot switch | Foot switch | Same |
| Maximum Patient Weight(kg) | | | 350<br>(Static, Center load) | 350<br>(Static, Center load) | Same |

| Manufacturer Contents | XGEO GC80<br>(K140334) | GC80 | Discussion |
|--------------------------------------|------------------------------|------------------------------|------------|
| (5)Collimator | | | |
| Overall Size(mm) | H212 X W300<br>X D179 | H212 X W300<br>X D179 | Same |
| Beam Limiting Blade<br>Moving Method | Motorized<br>/Manual | Motorized<br>/Manual | Same |
| Manual Operation Method | Volume | Volume | Same |
| Collimator Rotation | $ \pm $ 45 | $ \pm $ 45 | Same |
| Beam Light Source | LED | LED | Same |
| Light Field Indicator Timer | O | O | Same |
| Side Lamp | O | O | Same |
| Field Size / SID Display | Laser Module<br>Color LCD | Laser Module<br>Color LCD | Same |

| Manufacturer<br>Contents | XGEO GC80 (K140334) | GC80 | Discussion |
|--------------------------------------------------------------------------------------------------------|---------------------|------|------------|
| *NOTE: S3025-W detector as an option is added in the list of detectors used for XGEO GC80<br>(K140334) | | | |

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Image /page/8/Picture/1 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold letters. The background is a blue, oval shape.

510(k) Premarket Notification - Traditional

| Manufacturer<br>Contents | XGEO GC80 (K140334) | GC80 | Discussion |
|----------------------------------------------------|--------------------------|--------------------------|--------------------------|
| (6) Detector | | | |
| Name | S4335-W | S4343-W | S3025-W |
| | Csl | Csl | Csl |
| Detector Type | Indirect | Indirect | Indirect |
| Detector Area | 14"X17"<br>(345mmX425mm) | 17"X17"<br>(425mmX425mm) | 10"X12"<br>(245mmX295mm) |
| Number of pixels | 2466X3040 | 3036X3040 | 1750X2108 |
| Pixel Pitch(um) | 140 | 140 | 140 |
| High Contrast<br>Limiting<br>Resolution<br>(LP/mm) | 3.57 | 3.57 | 3.57 |
| Communication | Wired / Wireless | Wired / Wireless | Wired / Wireless |

| No | Differences | Explanation |
|-----|---------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| (1) | Detector Area | Proposed medical device's detector has smaller area than the predicate device's detectors while technical specification is identical among them such as type & pixel pitch, and the smaller area does not contribute any adverse impacts to the predicate device's safety and performance. |
| (2) | Number of pixels<br>Resolution and pixel pitch<br>of detector | Proposed medical device's detector has smaller detector area. Therefore, the proposed medical device's numbers of pixels is smaller than the predicate device's detectors while pixel pitch is identical among them, and the smaller number of pixels does not contribute any adverse impacts to the predicate device's safety and performance. |

In non-clinical data, the propose detector shows curves and measurements of MTF and DQE that do not differ from the predicate device.

In clinical data, the radiologists evaluate the image of GC80 is substantially equivalent, and superior in some images to the predicate device.

### 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/9/Picture/1 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold, sans-serif font. The word is set against a blue, oval-shaped background.

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 satisfying the standards.

### 11. Non-clinical data

In non-clinical data, MTF and DQE were tested and measured by IEC 62220-1. The proposed device shows no different curves and measurements of MTF and DQE from the predicate device.

# 12. Clinical data

Clinical images were provided; these images were not necessary to establish substantial equivalence but they provide further evidence in addition to the laboratory performance data to show that the whole system works as intended.

# 13. Conclusions

The non-clinical and clinical data demonstrates that the proposed device is as safe, as effective, and performs as well as the legally marketed device identified in paragraph 6.

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