(29 days)
Not Found
No
The document describes standard digital X-ray imaging processes and image post-processing. While "Image Postprocessing Engine (IPE)" and "S-Enhance" are mentioned, there is no explicit mention of AI, ML, or any learning-based algorithms being used for image processing or feature enhancement. The descriptions of the software features (S-Enhance, PEM, Remote View) do not indicate the use of AI/ML.
No
The device is described as an X-ray imaging system used to generate radiographic images for diagnostic purposes (reading images), not for treating a condition.
Yes
This device is described as a "Digital Diagnostic X-ray System" in the Device Description, and its images are sent to PACS for "reading images," which implies diagnostic interpretation.
No
The device description explicitly lists numerous hardware components including HVG, U-arm positioner, X-ray tube, collimator, detector, etc., indicating it is a physical X-ray system with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The GU60A & GU60A-65 Digital X-ray Imaging Systems generate radiographic images by transmitting X-rays through the patient's body. They capture images of internal anatomy, not analyze samples taken from the body.
- Intended Use: The intended use clearly states generating radiographic images of human anatomy.
- Device Description: The description details the process of X-rays passing through the body and being converted into digital images. There is no mention of analyzing biological samples.
Therefore, the function and intended use of this device fall under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The GU60A & GU60A-65 Digital X-ray Imaging Systems are 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 GU60A, GU60A-65 digital X-ray imaging systems are a stationary x-ray system designed for general radiography and 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 Postprocessing Engine (IPE) which is exclusively installed in S-station, and sent to the Picture Archiving, Communication System (PACS) sever for reading images.
The GU60A, GU60A-65 digital X-ray imaging systems consist of HVG (High Voltage Generator), U-arm positioner, X-ray tube, collimator, detector, ACE (Auto Exposure Control), DAP (Dose Area Product), CIB (Control Interface Box), remote controller, grid, barcode scanner, auto-stitching stand, weight distribution cap and workstation for Sstation including Image Post-processing Engine (IPE).
The difference between GU60A and GU60A-65 is that the option of their HVG is different. In detail, 50 kW and 68 kW are for GU60A and 65 KW is for GU60A-65.
The GU60A, GU60A-65 digital X-ray imaging systems were previously cleared under K180543, and some hardware options and three software features are added to the predicate device GU60A, GU60A-65. The changes are as follows:
- Two detectors
- Software features called as S-Enhance, PEM (Pediatric Exposure Management) and Remote View
- The S-Enhance is optional software to improve clarity of a foreign body (e.g. tube, line) and stone in chest, abdomen and L-spine images. With a single onscreen click, the companion image is created without additional settings or xray exposure, streamlining the process.
- Pediatric Exposure Management is subdivided patient size and exposure conditions especially for pediatric patients based on weight and protocols. It follows same methodologies to define preset of patient size compare to preset of standard patient size from predicate device but specially optimized for pediatric patients.
- The Remote view function provided images on another PC, not just on the device.
Mentions image processing
Yes, "The captured images are tuned up by an Image Postprocessing Engine (IPE) which is exclusively installed in S-station, and sent to the Picture Archiving, Communication System (PACS) sever for reading images."
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
human anatomy
Indicated Patient Age Range
The Pediatric Exposure Management feature is specifically optimized for pediatric patients, indicating the device is intended for use across a range that includes pediatric patients.
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 testing data was provided in conformance to the FDA "Guidance for the Submission of 510(k)'s for Solid-State X-ray Imaging Devices", which includes MTF and DQE measurements as tested by IEC 62220-1. The verification and validation for the software features added to the proposed device were also conducted and reviewed in accordance with internal design change procedure. As a result, requirement specifications were met and the proposed device shows no difference in non-clinical testing data such as MTF and DQE measurements from the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Samsung Electronics Co., Ltd. Jaesang Noh Senior Professional, Regulatory Affairs 129, Samsung-ro, Yeongtong-gu Suwon-si. Gyeonggi-do. 16677 KOREA
Re: K182622
Trade/Device Name: GU60A, GU60A-65 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: KPR Dated: September 21, 2018 Received: September 24, 2018
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 (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 located 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.
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 803) for
October 23, 2018
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Digitally signed by Mich Michael D DN: c=US. o=U.S. Government HHS. ou=EDA. ou=People O'hara -S 2342.19200300.100.1.1=1300 6759, cn=Michael D. O'hara -S FOI Date: 2018.10.23 17:42:12 -04'00"
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
GU60A, GU60A-65
Indications for Use (Describe)
The GU60A & GU60A-65 Digital X-ray Imaging Systems are 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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3
Image /page/3/Picture/1 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white letters on a blue oval background. The oval is tilted slightly to the right.
510(k) Premarket Notification - Special
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted accordance with requirements of 21 CFR 807.92
-
- Date: September 21, 2018
2. Submitter
- A. Company Name: SAMSUNG ELECTRONICS Co., Ltd.
- Address: 129, Samsung-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do, 16677, B. Republic of Korea
3. Primary Contact Person
- A. Name: JAESANG NOH, CHUNSIN KIM
- B. Title: Regulatory Affairs, Senior Professional
- C. Phone Number: +82-2-2193-2444, +82-2-2193-2437
- D. FAX Number: +82-31-200-6401
- E. E-Mail: jaesang.noh@samsung.com, chulsin.kim@samsung.com
4. Secondary Contact Person
- A. Name: Genci Omari
- B. Title: Manager, Regulatory Affairs
- C. Phone Number: 978-564-8602
- D. FAX Number: 978-560-0602
- E-Mail: gomari@samsungneurologica.com ப்
5. Proposed Devices
- A. Trade Names: GU60A, GU60A-65
- B. Device Names: GU60A, GU60A-65
- C. Common Name: Digital Diagnostic X-ray System
- D. Regulation Name: Stationary X-ray system
- E. Requlation: 21 CFR 892.1680
- Product Code: KPR ட்
6. Predicate Device
| | Predicate Device #1
(Primary Predicate) | Predicate Device #2 |
|----------------------|--------------------------------------------|-------------------------|
| Device Name | GU60A, GU60A-65 | GC85A |
| Classification Name | Stationary X-ray System | Stationary X-ray System |
| Product Code | KPR | KPR |
| Regulation | 21 CFR 892.1680 | 21 CFR 892.1680 |
| 510(K)# | K180543 | K181629 |
| 510(K) Decision Date | May 24,2018 | July 20, 2018 |
7. Device Description
The GU60A, GU60A-65 digital X-ray imaging systems are a stationary x-ray system
4
Image /page/4/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 - Special
designed for general radiography and 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 Postprocessing Engine (IPE) which is exclusively installed in S-station, and sent to the Picture Archiving, Communication System (PACS) sever for reading images.
The GU60A, GU60A-65 digital X-ray imaging systems consist of HVG (High Voltage Generator), U-arm positioner, X-ray tube, collimator, detector, ACE (Auto Exposure Control), DAP (Dose Area Product), CIB (Control Interface Box), remote controller, grid, barcode scanner, auto-stitching stand, weight distribution cap and workstation for Sstation including Image Post-processing Engine (IPE).
The difference between GU60A and GU60A-65 is that the option of their HVG is different. In detail, 50 kW and 68 kW are for GU60A and 65 KW is for GU60A-65.
The GU60A, GU60A-65 digital X-ray imaging systems were previously cleared under K180543, and some hardware options and three software features are added to the predicate device GU60A, GU60A-65. The changes are as follows:
- Two detectors
- Software features called as S-Enhance, PEM (Pediatric Exposure Management) and Remote View
- The S-Enhance is optional software to improve clarity of a foreign body (e.g. tube, line) and stone in chest, abdomen and L-spine images. With a single onscreen click, the companion image is created without additional settings or xray exposure, streamlining the process.
- Pediatric Exposure Management is subdivided patient size and exposure conditions especially for pediatric patients based on weight and protocols. It follows same methodologies to define preset of patient size compare to preset of standard patient size from predicate device but specially optimized for pediatric patients.
- The Remote view function provided images on another PC, not just on the device.
8. Intended Use
The GU60A, GU60A-65 Digital X-ray Imaging Systems are 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 proposed device GU60A, GU60A-65 do not alter the intended use or the fundamental scientific technology and remains within the same classification regulation for the same intended use as the predicate devices #1 and 2 because the proposed device GU60A,
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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, bold letters against a blue, oval-shaped background. The oval is tilted slightly, giving the logo a dynamic appearance.
510(k) Premarket Notification - Special
GU60A-65 use the same detectors and the same software features called as S-Enhance, PEM and Remote View of the predicate device GC85A, which were cleared with K181629, as a selective option of X-ray configuration. Verification and validation testing for these changes were successfully conducted in accordance with Samsung Design Change Process.
The following tables compare the main technological characteristics of the proposed device with the predicate devices to substantiate equivalence.
A. Comparing with Predicate Devices
The components and software features added to the proposed device are identical to the predicate devices, which do not show significant difference in safety and effectiveness.
| Manufacturer
Contents | Predicate Device
#1
(Primary
Predicate) | Proposed Device | Predicate Device
#2 | Discussion |
|-------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Device Name | GU60A, GU60A-
65 | GU60A, GU60A-
65 | GC85A | |
| Manufacture | Samsung | Samsung | Samsung | |
| 510(k)
Number | K180543 | | K181629 | |
| Appearance | Image: X-ray machine | Image: X-ray machine | Image: X-ray machine | Same as PD#1 |
| Intended Use | The GU60A,
GU60A-65 Digital
X-ray Imaging
Systems are
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 GU60A,
GU60A-65 Digital
X-ray Imaging
Systems are
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 GC85A
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 as PD#1 |
| Manufacturer
Contents | Predicate Device
#1 | Proposed Device | Predicate Device
#2 | Discussion |
| (1) Detectors (Note: All detectors were 510(k) cleared with predicate #1, #2) | | | | |
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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 oval shape.
510(k) Premarket Notification - Special
| Name
(Model
Number) | S4335-W
S4343-W
S3025-W | S4335-W
S4343-W
S3025-W
S4335-AW
S4343-AW | S4335-AW
S4343-AW | S4335-AW
S4343-AW | S4335-W
S4343-W | S4335-AW
S4343-AW | Same as PD#2 |
|----------------------------------------------------|------------------------------------------------------------------------------------------------------|-------------------------------------------------------|------------------------------------------------------------------------------------------------------|------------------------------|------------------------------------------------------------------------------------------------------|------------------------------|--------------|
| Detector Type | Csl
Indirect | Csl
Indirect | Csl
Indirect | Csl
Indirect | Csl
Indirect | Csl
Indirect | Same
Same |
| Detector Area | 14"X17"(
345mmX
425mm) | 17"X17"(
425mmX
425mm) | 14"X17"(
345mmX
425mm) | 17"X17"(
425mmX
425mm) | 14"X17"(
345mmX
425mm) | 17"X17"(
425mmX
425mm) | Same
Same |
| Number of
pixels | 2466X30
40 | 3036X30
40 | 2466X30
40 | 3036X30
40 | 2466X30
40 | 3036X30
40 | Same
Same |
| Pixel Pitch(um) | 140 | 140 | 140 | 140 | 140 | 140 | Same |
| High Contrast
Limiting
Resolution
(LP/mm) | 3.57 | 3.57 | 3.57 | 3.57 | 3.57 | 3.57 | Same |
| Communicatio
n | Wired /
Wireless | Wired /
Wireless | Wired /
Wireless | Wired /
Wireless | Wired /
Wireless | Wired /
Wireless | Same |
| Dust/Water-
resistance | IPx1 | | IP54 | | IP54 | | Same as PD#2 |
| Max.load
capacity | 150 kg for uniform
load,
100 kg for local
load (40 mm in
diameter disk at
the center) | | 400 kg for uniform
load,
200 kg for local
load (40 mm in
diameter disk at
the center) | | 400 kg for uniform
load,
200 kg for local
load (40 mm in
diameter disk at
the center) | | Same as PD#2 |
| Manufacturer
Contents | Predicate Device
#1 | Proposed Device | Predicate Device
#2 | Discussion |
|--------------------------|------------------------|-----------------|------------------------|--------------|
| (2) Software Feature | | | | |
| Feature
Names | SimGrid | SimGrid | SimGrid | Same |
| | - | - | S-Guide | N/A |
| | TLE | S-Enhance | S-Enhance | Same as PD#2 |
| | - | PEM | PEM | Same as PD#2 |
| | S-DAP | S-DAP | S-DAP | Same |
| | S-Share | S-Share | S-Share | Same |
| | BSI | BSI | BSI | Same |
| | - | Remote View | Remote View | Same as PD#2 |
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, ISO14971, 21CFR1020.30 and 21CFR1020.31 were performed, and EMC testing was conducted in accordance with standard IEC 60601-1-2. Wireless function was tested and
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Image /page/7/Picture/1 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white letters on a blue background. The logo is simple and recognizable.
510(k) Premarket Notification - Special
verified followed by guidance, Radio frequency Wireless Technology in Medical Devices. All test results were satisfying the standards.
ﻥ Non-clinical data
Non-clinical testing data was provided in conformance to the FDA "Guidance for the Submission of 510(k)'s for Solid-State X-ray Imaging Devices", which includes MTF and DQE measurements as tested by IEC 62220-1. The verification and validation for the software features added to the proposed device were also conducted and reviewed in accordance with internal design change procedure. As a result, requirement specifications were met and the proposed device shows no difference in non-clinical testing data such as MTF and DQE measurements from the predicate device.
D. Clinical data
The application of detectors and software features, cleared with K181629, to the proposed device GU60A, GU60A-65 does not require clinical data.
Conclusions ய்
Non-clinical data demonstrates that the proposed devices are as safe, as effective, and perform as well as the legally marketed predicate devices.