Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details standard digital X-ray imaging system components and image processing steps (amplification, digital conversion, DICOM saving). There is no mention of AI, ML, or any algorithms that would suggest learning or adaptive capabilities. The performance studies focus on standard imaging metrics (MTF, DQE) and clinical image evaluation for substantial equivalence, not AI/ML performance metrics.

Therapeutic

No.
The device is described as an X-ray imaging system intended to generate radiographic images for diagnosis, not for treating any condition.

Diagnostic

No

The device is an imaging system used to generate radiographic images of human anatomy for a qualified/trained doctor or technician to read. It produces images, but does not itself provide a diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly lists numerous hardware components (High voltage generator, X-ray tube, Detector, etc.) that are integral to the device's function of generating radiographic images. While it includes software (S-Station), it is part of a larger hardware system.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The description clearly states that the GC80 Series Digital X-ray imaging System is used for "generating radiographic images of human anatomy" by transmitting X-rays through the body. It captures images of internal structures.
No Sample Analysis: There is no mention of the device analyzing biological samples or performing tests on bodily fluids or tissues. Its function is purely imaging.

Therefore, the GC80 Series Digital X-ray imaging System falls under the category of a medical imaging device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

KPR

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.

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:
Study Type: Performance testing according to standards.
Key Results: 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 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.
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.

Clinical data:
Study Type: Clinical images evaluation.
Key Results: 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. In clinical data, the radiologists evaluate the image of GC80 is substantially equivalent, and superior in some images to the predicate device.

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

Not Found

Predicate Device(s)

K140334

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 892.1680 Stationary x-ray system.

(a)
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.(b)
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.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol often associated with healthcare. The caduceus in the logo is depicted with three intertwined strands.

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

1

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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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

2

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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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
1. 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: +82-31-200-7661
D. FAX Number: +82-31-200-1199 E-Mail: chulsin.kim@samsung.com

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: dfickett@samsungneurologica.com

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
Appearances		Same
Intended Use	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.	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.	Same

| Manufacturer Contents | XGEO GC80
(K140334) | GC80 | Discussion | |
|----------------------------------------------|------------------------|----------------|--------------|------|
| (1)High Voltage Generator | | | | |
| Type | High Frequency | High Frequency | Same | |
| Max. Power | 80kW | 80kW | Same | |
| Output
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
(Automatic Exposure Control) | Yes | Yes | Same | |
| APR (Anatomically
Programmed Radiography) | Yes | Yes | Same | |

| Manufacturer Contents | XGEO GC80
(K140334) | GC80 | Discussion | |
|-------------------------|------------------------|-----------------------------------------|-----------------------------------------|------|
| (2)Ceiling Suspension | | | | |
| Moving
Range
(mm) | Longitudinal | 16804180
(Varies with room
size) | 16804180
(Varies with room
size) | Same |
| | Lateral | 10303030
(Varies with room
size) | 10303030
(Varies with room
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
(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

Touch Screen | Button
Touch Screen | Same |
| Vertical Sync. | With Table | O | O | Same |
| | With Stand | O | O | Same |

| Manufacturer Contents | (K140334) | GC80 | Discussion |
----------------------|-------------------|-------------------------------------------|-------------------------------------------|------------|
| | | | |
| Vertical
| Motorized/
| Motorized/
|
| Range(mm) | 400~~1800 | 400~~1800 | Same |
| | Yes | Yes | Same |
| Mechanism | Motorized | Manual | Same |
| Range | -20~+90 | -20~+90 | Same |
| | Conventional | Conventional | Same |
| Lines/cm | 84.6 | 84.6 | Same |
| Grid
| Stationary | Same |
| | | | |
| Removability | Removable | Removable | Same |
| | Floor | Floor | Same |
| | Patient handgrips,
handgrips,

| Manufacturer Contents | XGEO GC80
(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
(K140334) | GC80 | Discussion |
|----------------------------------|-----------------------|-------------------------|------------------------------|------------------------------|------------|
| | Range
e
(mm) | Lateral
Longitudinal | ±140
±480 | ±140
±480 | Same |
| Table
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
(Static, Center load) | 350
(Static, Center load) | Same |

| Manufacturer Contents | XGEO GC80
(K140334) | GC80 | Discussion |
|--------------------------------------|------------------------------|------------------------------|------------|
| (5)Collimator | | | |
| Overall Size(mm) | H212 X W300
X D179 | H212 X W300
X D179 | Same |
| Beam Limiting Blade
Moving Method | Motorized
/Manual | Motorized
/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
Color LCD | Laser Module
Color LCD | Same |

| Manufacturer

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

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"
(345mmX425mm)	17"X17"
(425mmX425mm)	10"X12"
(245mmX295mm)
Number of pixels	2466X3040	3036X3040	1750X2108
Pixel Pitch(um)	140	140	140
High Contrast
Limiting
Resolution
(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
Resolution and pixel pitch
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.

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