GF85 (models GF85-3P, GF85-SP)

• K Number: K242478
• Device Name: GF85 (models GF85-3P, GF85-SP)
• Manufacturer: Samsung Electronics Co., Ltd.
• Date Cleared: 2024-09-19 ( 29 days)
• Product Code: KPR
• Regulation Number: 892.1680

Intended Use

The GF85 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 Description

The GF85 digital X-ray imaging 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 on the S-station, which is the Operation Software (OS) of Samsung Digital Diagnostic X-ray System, and save in DICOM file, a standard for medical imaging. The captured images are tuned up by an Image Post-processing Engine (IPE) which is exclusively installed in S-station, and sent to the Picture Archiving & Communication System (PACS) sever for reading images. The GF85 Digital X-ray Imaging System includes two models, namely the GF85-3P and GF85-SP. These two models differ primarily in terms of their respective configurations of High Voltage Generators (HVGs). Specifically, the GF85-3P features capacities of 80 kW, 65 kW and 50 kW with 3 phases, whereas the GF85-SP provides a capacity of 40 kW with a single phase. However, all other specifications remain consistent across both models.

Predicate Devices

K181629, K222353

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description mentions image post-processing but does not include any terms or descriptions indicative of AI or ML technology.

Therapeutic

No
The device is described as an imaging system used to generate radiographic images for diagnosis, not for treating conditions or diseases.

Diagnostic

Yes

Explanation: The device description explicitly states that the GF85 system is used with "S-station, which is the Operation Software (OS) of Samsung Digital Diagnostic X-ray System," directly labeling it as part of a diagnostic system. Additionally, its function is to generate radiographic images of human anatomy for "reading images," which is a key step in diagnosis.

SaMD (Software as a Medical Device)

No

The device description clearly outlines hardware components like X-ray generators, detectors, and a signal processing unit (S-station) which is the OS but also handles hardware signal processing. The differences between models are based on High Voltage Generator configurations.

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. These tests are performed outside of the body (in vitro).
• Device Function: The GF85 Digital X-ray Imaging System generates radiographic images by transmitting X-rays through the patient's body. This is an in vivo (within the living body) imaging process, not an in vitro diagnostic test on a sample.
• Intended Use: The intended use is to generate radiographic images of human anatomy, which is a form of medical imaging for diagnosis or assessment, not an in vitro diagnostic test.

The device description clearly outlines a process of capturing images by passing X-rays through the patient and converting them into digital data for viewing and storage. This aligns with the function of a medical imaging system, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The GF85 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 GF85 digital X-ray imaging 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 on the S-station, which is the Operation Software (OS) of Samsung Digital Diagnostic X-ray System, and save in DICOM file, a standard for medical imaging. The captured images are tuned up by an Image Post-processing Engine (IPE) which is exclusively installed in S-station, and sent to the Picture Archiving & Communication System (PACS) sever for reading images. The GF85 Digital X-ray Imaging System includes two models, namely the GF85-3P and GF85-SP. These two models differ primarily in terms of their respective configurations of High Voltage Generators (HVGs). Specifically, the GF85-3P features capacities of 80 kW, 65 kW and 50 kW with 3 phases, whereas the GF85-SP provides a capacity of 40 kW with a single phase. However, all other specifications remain consistent across both models.

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: The basic dosimetric performance data of the proposed device and predicate device were compared and the proposed device has the similar characteristics in the exposure output and Half Value Layer even for different tube combinations. The phantom image evaluations were performed in accordance with the FDA guidance for the submission of 510(k)'s for Solid State X-ray Image Devices and were evaluated by three different professional radiologists and found to be equivalent to the predicate device. These reports show that the proposed device is substantially equivalent to the proposed devices.

Clinical data: This submission does not required clinical data. Testing for image quality has been conducted with image phantoms, as described above.

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

Not Found

Predicate Device(s)

K181629, K222353

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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font below.

September 19, 2024

Samsung Electronics Co., Ltd. % Jaesang Noh Regulatory Affairs, Principal Professional 129, Samsung-ro, Yeongtong-gu Suwon-si, Gyeonggi 16677 SOUTH KOREA

Re: K242478

Trade/Device Name: Gf85 (models gf85-3p, gf85-sp) Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary X-Ray System Regulatory Class: Class II Product Code: KPR Dated: August 19, 2024 Received: August 21, 2024

Dear Jaesang Noh:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Lu Jiang

Lu Jiang, Ph.D. Assistant Director Diagnostoc X-Ray Systems Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

3

Indications for Use

510(k) Number (if known) K242478

Device Name GF85 (models GF85-3P, GF85-SP)

Indications for Use (Describe)

"The GF85 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)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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SAMSUNG

SAMSUNG ELECTRONICS Co., Ltd.

510(k) Premarket Notification - Traditional

K242478 510(k) Summary

This 510k Summary is being submitted in accordance with the requirements of 21 CFR 807.92.

• 1. Date: August 19, 2024

2. Submitter

• A. Company Name: SAMSUNG ELECTRONICS Co., Ltd.
• B. Address: 129, Samsung-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do, 16677, Republic of Korea

3. Primary Contact Person

• A. Name: JAESANG NOH
• B. Title: Regulatory Affairs, Principal Professional
• C. Phone Number: [phone]
• D. FAX Number: [phone]
• E. E-Mail: [e-mail]

4. Secondary Contact Person

• A. Name: Ninad Gujar
• B. Title: Vice President, Requlatory Affairs & Quality Control
• C. Phone Number: 978-564-8503
• D. FAX Number: 978-560-0602
• E. E-Mail: [e-mail]

Proposed Device 5.

• A. Trade Name: GF85 (models GF85-3P, GF85-SP)
• B. Device Model Names: GF85-3P, GF85-SP
• C. Common Name: Stationary X-ray System
• D. Classification Name: System, X-ray, Stationary
• E. Product Code: KPR
• ட் Regulation: 21 CFR 892.1680

6. Predicate Devices

	Predicate Device #1	Predicate Device #2
Device Name	GC85A	GM85
Classification Name	Stationary X-ray System	Mobile X-ray System
Product Code	KPR	IZL
Regulation	21 CFR 892.1680	21 CFR 892.1720
510(K)#	K181629	K222353
510(K) Decision Date	July 20, 2018	September 29, 2022

7. Device Description

The GF85 digital X-ray imaging system is used to capture images by transmitting X-ray

5

510(k) Premarket Notification - Traditional

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 on the S-station, which is the Operation Software (OS) of Samsung Digital Diagnostic X-ray System, and save in DICOM file, a standard for medical imaging. The captured images are tuned up by an Image Post-processing Engine (IPE) which is exclusively installed in S-station, and sent to the Picture Archiving & Communication System (PACS) sever for reading images. The GF85 Digital X-ray Imaging System includes two models, namely the GF85-3P and

GF85-SP. These two models differ primarily in terms of their respective configurations of High Voltage Generators (HVGs). Specifically, the GF85-3P features capacities of 80 kW, 65 kW and 50 kW with 3 phases, whereas the GF85-SP provides a capacity of 40 kW with a single phase. However, all other specifications remain consistent across both models.

8. Intended Use

The GF85 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

Though the gantry of the proposed device, GF85, is newly designed, it has the same detectors and image processing as predicate devices. Therefore, it does not have significant changes in image characteristics compared to the predicate device #1 and #2, GC85A and GM85.

Comparisons of technological characteristics were executed and demonstrate the substantial equivalence to the predicate devices.

Attribute	Predicate Device #1	Proposed Device	Predicate Device #2	Comparison Results
Name	GC85A	GF85
(GF85-3P/GF85-SP)	GM85
Manufacturer	SAMSUNG
ELECTRONICS
Co., Ltd.	SAMSUNG
ELECTRONICS
Co., Ltd.	SAMSUNG
ELECTRONICS
Co., Ltd.
510(k) Number	K181629	None	K222353
Appearances	Image: GC85A	Image: GF85	Image: GM85	Similar as PD #1
Intended Use	The GC85A digital
X-ray imaging
system is intended
for use in	The GF85 Digital X-
ray Imaging System
is intended for use
in generating	The GM85 Digital
Mobile X-ray
imaging System is
intended for use in	Same as PD #1

A. Comparing with Predicate Devices

6

SAMSUNG

| generating
radiographic images
of human anatomy
by a
qualified/trained
doctor or technician.
This device is not
intended for
mammographic
applications. | radiographic images
of human anatomy
by a
qualified/trained
doctor or technician.
This device is not
intended for
mammographic
applications. | generating
radiographic images
of human anatomy
by a
qualified/trained
doctor or technician.
This device is not
intended for
mammographic
applications. |

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	----------------------------------------------------------------------------------------------------------------------------------------------------------------------	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

| Attribute | Predicate Device #1
(GC85A, K181629) | | GF85 | | Comparison Results |
|----------------------------------------------------|-----------------------------------------|--------------------------------------------------------|-----------------------------------------------------------|---------------|--------------------|
| | | GF85-3P | GF85
-SP | | |
| (1)High Voltage Generator | | | | | |
| Name | GXR-82 | GXR-52
ZR75 PN80
ZR75 PN50 | Cetus 80R01
Cetus 65R01
Cetus 50R01
Cetus 40R03 | Different (1) | |
| Max. Power | 82kW | 52kW
80kW
50kW | 80kW
65kW
50kW
40kW | Different (1) | |
| Output
RANGE | Tube Voltage | 40-150kV | | Same | |
| | Tube Current | 10-
1000 mA
10-640m A
10-1000 mA
10-630m A | 10 ~ 1000 mA
10 ~ 800 mA
10 ~ 630 mA
10 ~ 500 mA | Different (1) | |
| | Exposure Time | 1msec-10sec | | Same | |
| AEC
(Automatic
Exposure
Control) | | Yes | | Same | |
| APR
(Anatomically
Programmed
Radiography) | | Yes | | Same | |

| Attribute | Predicate Device #1
(GC85A, K181629) | GF85 | | | Comparison Results | |
|-----------------|-----------------------------------------|--------------------------------------|-------------------|------------------|--------------------|---------------|
| (2) X-ray tube | | | | | | |
| Name | E7869X | E7252X | H2100X
E7254FX | H1080X
E7252X | H1086X
E7843X | Different (2) |
| Focal spot | 0.6/1.2mm | 0.6/1.2mm | | | | Same |
| Target Angle | 12° | 12° | | | | Same |
| Target Material | Rhenium-tungsten faced
molybdenum | Rhenium-tungsten faced
molybdenum | | | | Same |

7

SAMSUNG

| Attribute | Predicate Device #1
(GC85A, K181629) | GF85 | Comparison Results | |
|---------------------------------|-------------------------------------------|-------------------------------------------|-----------------------|---------------|
| Max. Anode HU | 600kHU | 400kHU 300kHU 150KHU | Different (2) | |
| Attribute | Predicate Device #1
(GC85A, K181629) | GF85 | Comparison Results | |
| (3) Tube Stand | | | | |
| Moving Range (mm) | Longitudinal | 1,6804,180
(Varies with room size) | 2,100 | Different (3) |
| | Lateral | 1,0303,030
(Varies with room size) | 150 | Different (3) |
| | Vertical | 1,800 | 1,500 | Different (3) |
| | Vertical Tube Moving method | Motorized | Manual & Motorized | Different (3) |
| | Tube Assembly Rotation | -157 ~ +183 | ±90° | Different (3) |
| | Brake locking Method | Electromagnetic | Electromagnetic | Same |
| | Automatic Centering | O | O | Same |
| | Moving Rail Type | Al Extrusion | Steel | Different (3) |
| | 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 |
| | Tube Support Mounting | Ceiling-mounted | Floor-mounted | Different (3) |
| Attribute | Predicate Device #1
(GC85A, K181629) | GF85 | Comparison Results | |
| Move
ment | Range
(mm) | 2801,850 | 4001,900 | Different (4) |
| Detector/tube
servo coupling | Yes | Yes | Same | |
| Detect
or | Tilting | Motorized | Motorized | Same |
| | | -20~+90 / N/A | -20~+90 / N/A | Same |
| | AEC | Conventional | Conventional | Same |
| | Lines/
cm | 85/92 | 85 | Same |
| Grid | Grid
mecha
nism | Stationary | Stationary | Same |
| | Remo
vability | Removable | Removable | Same |
| | | | | |
| Detector
Support
Mounting | Floor | Floor | Same | |
| Patient Support
Device | Patient handgrips, lateral
support bar | Patient handgrips, lateral
support bar | Same | |

Attribute	Predicate Device #1 (GC85A, K181629)		GF85	Comparison Results
(4) Wall Stand
Vertical	Mechanism	Motorized	Manual & Motorized	Different (4)

8

SAMSUNG

| Attribute | Predicate Device #1
(GC85A, K181629) | GF85 | Comparison Results | |
|----------------------------------|-----------------------------------------|--------------|------------------------|---------------|
| (5) Patient Table | | | | |
| Table Top | Size(mm) | 2,410 X 812 | 2,208 X 800 | Different (5) |
| | Range (mm) | $\pm$ 140 | $\pm$ 105 | Different (5) |
| | Range (mm) | $\pm$ 480 | $\pm$ 400 | Different (5) |
| Table height | Mechanism | Motorized | Motorized / Fixed | Same |
| | Range (mm) | 545 ~ 900 | 500 ~770 / 680 (Fixed) | Different (5) |
| Horizontal range of detector(mm) | | 688 | 600 | Different (5) |
| AEC | | Conventional | Conventional | Same |
| Grid | Lines/cm | 85/92 | 85 | Same |
| | Grid mechanism | Stationary | Stationary | Same |

9

SAMSUNG

| Attribute | Predicate Device #1
(GC85A, K181629) | GF85 | Comparison Results |
|--------------------------------------------------------------|-----------------------------------------|------------------------|--------------------|
| Removability | Removable | Removable | Same |
| Vertical Sync. | O | O / Fixed | Different (5) |
| Control Switch
Type | Foot switch | Foot switch | Same |
| Maximum
Patient
Weight(kg)
(Static, Center
load) | 350 | 350 (CFRP) / 300 (HPL) | Different (5) |

| Attribute | Predicate Device #1
(GC85A, K181629) | GF85 | Comparison Results |
|-----------------------------------------|-------------------------------------------------------|----------------------------|--------------------|
| (6) Collimator | | | |
| Name | SDR-OGCL80
U
SDR-OGCL81
U
SDR-OGCL83
U | SDR-OGCL20P
SDR-OGCL21P | Different (6) |
| Beam Limiting
Blade/Moving
Method | Motorized
/Manual | Motorized
/Manual | Same |
| Manual
Operation
Method | Volume | Volume | Same |
| Collimator
Rotation | ±45 | -90°/+180° | Different (6) |
| Beam Light
Source | LED | LED | Same |
| Light Field
Indicator Timer | O | O | Same |
| Side Lamp | O | O | Same |
| | Laser Module | Laser Module | Same |
| Field Size / SID
Display | Color LCD | Color LCD | Same |

| Attribute | Predicate Device #2
(GM85, K222353) | GF85 | Comparison Results |
|--------------|----------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|--------------------|
| (7) Detector | | | |
| Name | S4335-W
S4343-W
S3025-W
S4335-AW
S4343-AW
S4335-AWM
S4343-AWM
S3025-AW
S3025-AWM
F4335-AW | S4335-AW
S4343-AW
S4335-AWM
S4343-AWM
S3025-AW
S3025-AWM
F4335-AW | Same |

10

SAMSUNG

| Attribute | Predicate Device #1
(GC85A, K181629) | GF85 | Comparison Results |
|-----------------------------|-----------------------------------------|------------------|--------------------|
| (8) Weight Distribution Cap | | | |
| W x L x H (mm) | 505 X 553 X 37.0 | 505 X 553 X 37.0 | Same |

| Attribute | Predicate Device #1
(GC85A, K181629) | GF85 | Predicate Device #2
(GM85, (K222353) | Comparison Results |
|-----------------------|-----------------------------------------|------------------------------|-----------------------------------------|--------------------|
| (9) Software Features | | | | |
| Feature
Names | S-Share | S-Share | S-Share | Same |
| | S-Enhance | S-Enhance | S-Enhance | Same |
| | SimGrid | SimGrid | SimGrid | Same |
| | - | PEM | PEM | Same |
| | QAP | QAP | QAP | Same |
| | Bone Suppression | Bone Suppression | Bone Suppression | Same |
| | Remote View | Remote View | Remote View | Same |
| | Smart Stitching | Smart Stitching | - | Same |
| | - | Mirror View | Mirror View | Same |
| | - | RFID | RFID. | Same |
| | - | Vision Live | - | Different (7) |
| | - | Vision Stitching | - | Different (7) |
| | - | Vision Capture | - | Different (7) |
| | - | Virtual Remote
Controller | - | Different (7) |

11

SAMSUNG

510(k) Premarket Notification - Traditional

| Attribute | Predicate Device #1
(GC85A, K181629) | GF85 | Predicate Device #2
(GM85, (K222353) | Comparison Results |
|-----------------------------------|--------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|--------------------|
| | - | Lunit INSIGHT CXR Triage | - | Different (7) |
| Attribute | Predicate Device #1
(GC85A, K181629) | GF85 | Predicate Device #2
(GM85, (K222353) | Comparison Results |
| (10) Image Post-processing Engine | | | | |
| Noise reduction
algorithm | Image Post-
processing Engine
with an advanced
noise reduction
algorithm | Image Post-
processing Engine
with an advanced
noise reduction
algorithm | Image Post-
processing Engine
with an advanced
noise reduction
algorithm | Same |

No	Comparison Results	Discussion
(1)	High Voltage Generator	The High Voltage Generators are different from the
predicate device, which have various Max. Power and
Output Range for the Tube Current. They do not contribute
any adverse impact to the device's safety and effectiveness.
(2)	X-ray tube	The X-ray tube are different from the predicate device,
which have different Max. Anode HU. They do not contribute
any adverse impact to the device's safety and effectiveness.
(3)	Tube Stand	The Tube Stand is different from the predicated device,
which have different Moving Range, Vertical Tube Moving
method, Tube Assembly Rotation, Moving Rail Type and
Tube Support Mounting because it's a floor-mounded type
in the proposed device. It does not contribute any adverse
impact to the device's safety and effectiveness.
(4)	Wall Stand	The Wall Stand different from the predicate device, which
have different Vertical Movement. It does not contribute any
adverse impact to the device's safety and effectiveness.
(5)	Patient Table	The Patient Table is different from the predicate device,
which has different Table Top, Table height, Horizontal
range of detector, Vertical Sync. and Maximum Patient
Weight. It does not contribute any adverse impact to the
device's safety and effectiveness.
(6)	Collimator	The Collimator is different from the predicate device, which
have different Collimator Rotation. It does not contribute any
adverse impact to the device's safety and effectiveness.
(7)	Software	New features are provided for user convenience. It does not
contribute any adverse impact to the device's safety and
effectiveness.

B. 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, ISO 14971, 21 CFR1020.30 and 21 CFR1020.31 were performed, and EMC testing was conducted in accordance with standard IEC 60601-1-2. Wireless function was tested and

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510(k) Premarket Notification - Traditional

verified followed by guidance, Radio frequency Wireless Technology in Medical Devices. All test results were satisfying the standards.

C. Non-clinical data

In the non-clinical data, the basic dosimetric performance data of the proposed device and predicate device were compared and the proposed device has the similar characteristics in the exposure output and Half Value Layer even for different tube combinations. The phantom image evaluations were performed in accordance with the FDA guidance for the submission of 510(k)'s for Solid State X-ray Image Devices and were evaluated by three different professional radiologists and found to be equivalent to the predicate device. These reports show that the proposed device is substantially equivalent to the proposed devices.

D. Clinical data

This submission does not required clinical data. Testing for image quality has been conducted with image phantoms, as described above.

• E. Summary of the Standards and Guidance Compliance
  • 1. ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012 C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] Medical Electrical Equipment -Part 1: General requirements for basic safety and essential performance
  • IEC 60601-1-2 Edition 4.1 Medical Electrical Equipment Part 1-2: General 2. Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic compatibility - Requirements and Tests
  • 3. IEC 60601-1-3 Edition 2.2 Medical Electrical Equipment – Part 1-3: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Radiation protection in Diagnostic X-ray Equipment
  • 4. IEC 60601-2-28 Edition 3 Medical Electrical Equipment – Part 2-28: Particular Requirements for the Basic Safety and Essential Performance of X-ray Tube Assemblies for Medical Diagnosis
  • 5. IEC 60601-2-54 Edition 2.0 Medical Electrical Equipment – Part 2-54: particular Requirements for the Basic Safety and Essential Performance of X-ray Equipment for Radiography and Radioscopy
  • 6. IEC 62220-1-1 Edition 1.0 Medical electrical Equipment - Characteristics of digital X-ray imaging devices Part 1-1: Determination of the detective quantum efficiency Detectors used in radiographic imaging
  • 7. Cybersecurity in Medical Device: Quality System Considerations and Content of Premarket Submissions issued on September 27, 2023
  • 8. Content of Premarket Submissions for Device software Functions issued on June 14, 2023
  • Guidance for the Submission for 510(k) for Solid State X-ray Imaging Devices 9. Guidance for Industry and Food and Drug Administration Staff issued on September 1, 2016
  • 10. Pediatric Information for X-ray Imaging Device Premarket Notifications Guidance for Industry and Food and Drug Administration Staff issued on November 28, 2017

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SAMSUNG

SAMSUNG ELECTRONICS Co., Ltd.

510(k) Premarket Notification - Traditional

F. Conclusion

The non-clinical data demonstrates that the proposed device is as safe, as effective, and performs as well as the legally marketed devices indicating substantial equivalence to the predicate.