(84 days)
Not Found
Unknown
The document describes an "advanced noise reduction algorithm" within the Image Post-processing Engine (IPE). While "advanced" could potentially imply AI/ML, the description focuses on traditional image processing techniques (region-of-interest extraction, tonescale mapping, noise reduction, texture restoration) and doesn't explicitly mention AI, ML, or related terms. Without further information, it's not possible to definitively confirm or deny the presence of AI/ML.
No.
The device is described as an X-ray imaging system used for generating radiographic images, which is a diagnostic tool, not a therapeutic one. Its function is to capture images, not to treat or cure conditions.
Yes
The "Intended Use / Indications for Use" states that the device is "intended for use in generating radiographic images of human anatomy." The "Device Description" also mentions that the "S-station" is the "Operation Software (OS) of Samsung Digital Diagnostic X-ray System," strongly implying a diagnostic purpose.
No
The device description explicitly states that the systems are used to capture images by transmitting X-rays to a patient's body and that the X-ray passing through the body is sent to a detector and converted into electrical signals. This indicates the presence of hardware components (X-ray source, detector) which are integral to the device's function. While the submission focuses on the Image Post-processing Engine (IPE) software, the overall device is a digital X-ray imaging system, not a software-only device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue). The intended use and device description clearly state that this system generates radiographic images by transmitting X-rays through the human body.
- The device description focuses on image acquisition, processing, and storage. It describes how X-rays are converted into digital signals and processed to create images for diagnosis. This is characteristic of an imaging device, not an IVD.
- The performance studies evaluate image quality metrics (MTF, CNR, visibility) and dose reduction. These are relevant to the performance of an X-ray imaging system, not an IVD.
The device is a Digital X-ray Imaging System, which is a type of medical imaging device used for diagnostic purposes, but it does not fall under the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The GC70 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 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 GF50 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 GF50A 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 GR40CW Digital X-ray Imaging System is intended for use in general projection radiographic applications wherever conventional screen-film systems or CR systems may be used. This device is not intended for mammographic applications.
The GM85 Digital Mobile X-ray imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Product codes (comma separated list FDA assigned to the subject device)
KPR, MQB, IZL
Device Description
GC70, GU60&GU60A-65, GF50, GF50A, GR40CW and GM85 are 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.
An IPE operates, from the input image, the roles of a region-of-interest extraction, tonescale mapping, noise reduction and texture restoration. The IPE employing an advanced noise reduction algorithm is shown that the image quality of PA radiograph for average adult chest, exposed at the condition of 50% lower dose at Entrance Skin Exposure (ESE) in comparison with the condition of the conventional noise reduction algorithm, is substantially equivalent. It was cleared with K172229 that using the IPE is able to reduce dose of 50% for chest PA of average adult in GC85A.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Human anatomy, specifically chest for PA radiograph mentions
Indicated Patient Age Range
Not Found. It states "The pediatric patients was not studied and the clinical site is responsible for determining whether the particular radiographic imaging needs are not impacted by such x-ray dose reduction."
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
The quantitative assessment of image quality was conducted with the images of TOR CDR radiography phantom and TO20 contrast detail phantom taken at a various exposure condition with different Samsung X-ray imaging systems. Modulation Transfer Function (MTF), Contrast to Noise (CNR) and visibility of the images were measured and compared.
A small clinical study at one facility was conducted, but details on sample size, data source, or annotation protocol are not provided.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Non-clinical evaluation and limited clinical study at one facility.
Sample Size: Not specified for the clinical study, but states "small clinical study". Non-clinical phantom study mentioned.
Key Results: The testing shows that the image quality produced by the subject devices and predicate GC85A are substantially equivalent when used at the same dose levels. Therefore, the IPE is capable of providing the same dose reduction in AP adult chest radiographs for the proposed devices as it does for the predicate GC85A. This claim is based on a limited study of an anthropomorphic phantom that simulates the x-ray properties of an average size adult, and on a small clinical study at one facility. Only routine PA chest radiography was studied, and results for larger-size adults (body mass index) greater than 30 was not studied to statistical significance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Modulation Transfer Function (MTF), Contrast to Noise (CNR) and visibility of the images were measured and compared.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K163115, K173828, K140326, K151419, K153401, K171119, K172229
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
May 24, 2018
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
SAMSUNG ELECTRONICS CO.,LTD. % Jaesang Noh Senior Professional, Regulatory Affairs 129, Samsung-ro, Yeongtong-gu Suwon-si. Gyeonggi-do 16677 REPUBLIC OF KOREA
Re: K180543
Trade/Device Name: GC70. GU60A&GU60A-65. GF50. GF50A. GR40CW. and GM85 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: May 4, 2018 Received: May 7, 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. 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); good manufacturing practice requirements as set 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.
1
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.
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,
Jo Delfino
for
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
Indications for Use
510(k) Number (if known)
Device Name GC70
Indications for Use (Describe)
The GC70 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
3
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) | |
|---|---|
| -- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
4
Indications for Use
510(k) Number (if known)
Device Name GF50
Indications for Use (Describe)
The GF50 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.
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------------------ | ----------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Type of Use (Select one or both, as applicable)
5
Indications for Use
510(k) Number (if known)
Device Name GF50A
Indications for Use (Describe)
The GF50A 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.
Prescription Use (Part 21 CFR 801 Subpart D) ] Over-The-Counter Use (21 CFR 801 Subpart C) CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Druq Administration
Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Type of Use (Select one or both, as applicable)
6
Indications for Use
510(k) Number (if known)
Device Name GR40CW
Indications for Use (Describe)
The GR40CW Digital X-ray Imaging System is intended for use in general projection radiographic applications wherever conventional screen-film systems or CR systems may be used. 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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect
and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
7
Indications for Use
510(k) Number (if known)
Device Name GM85
Indications for Use (Describe)
The GM85 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
8
Image /page/8/Picture/2 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white, set against a blue oval background. The oval is tilted slightly upwards from left to right.
510(k) Premarket Notification - Traditional
Section 5: 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted accordance with requirements of 21 CFR 807.92
-
- Date: February 28, 2018
2. Submitter
- Company Name: SAMSUNG ELECTRONICS Co., Ltd. A.
- B. Address: 145, Pangyoyeok-ro, Bundang-gu, Seongnam-si, Gyeonggi-do, 13530, Republic of Korea
3. Primary Contact Persons
- A. Name: Jaesang NOH & Chulsin KIM
- B. Title: Regulatory Affairs Senior Professional
- C. Phone Number: +82-2-2193-2444 & +82-2-2193-2437
- FAX Number: +82-31-200-6401 D. E-Mail: jaesang.noh@samsung.com & chulsin.kim@samsung.com
4. Secondary Contact Person
- Name: Genci Omari A.
- B. Title: Manager, Regulatory Affairs
- C. Phone Number: 978-564-8602
- D. FAX Number: 978-560-0602 E-Mail: gomari@samsungneurologica.com
5. Proposed Device
| Proposed Devices | ||||||
|---|---|---|---|---|---|---|
| #1 | #2 | #3 | #4 | #5 | #6 | |
| Trade | ||||||
| Name | GC70 | GU60A&GU60 | ||||
| A-65 | GF50 | GF50A | GR40C | |||
| W | GM85 | |||||
| Device | ||||||
| Name | GC70 | GU60A&GU60 | ||||
| A-65 | GF50 | GF50A | GR40C | |||
| W | GM85 | |||||
| Common | ||||||
| Name | Digital | |||||
| Diagnosti | ||||||
| c X-ray | ||||||
| System | Digital | |||||
| Diagnostic X- | ||||||
| ray System | Digital | |||||
| Diagnosti | ||||||
| c X-ray | ||||||
| System | Digital | |||||
| Diagnosti | ||||||
| c X-ray | ||||||
| System | Retrofit | |||||
| Kit | Digital | |||||
| Diagnosti | ||||||
| c Mobile | ||||||
| X-ray | ||||||
| System | ||||||
| Classificatio | ||||||
| n Name | Stationary | |||||
| X-ray | ||||||
| System | Stationary X- | |||||
| ray System | Stationary | |||||
| X-ray | ||||||
| System | Stationary | |||||
| X-ray | ||||||
| System | Solid | |||||
| State X- | ||||||
| ray | ||||||
| Imager | Mobile X- | |||||
| ray | ||||||
| System | ||||||
| Product | ||||||
| Code | KPR | KPR | KPR | KPR | MQB | IZL |
| Regulation | 21 CFR | |||||
| 892.1680 | 21 CFR | |||||
| 892.1680 | 21 CFR | |||||
| 892.1680 | 21 CFR | |||||
| 892.1680 | 21 CFR | |||||
| 892.168 | 21 CFR | |||||
| 892.1720 |
9
Image /page/9/Picture/1 description: The image shows the Samsung logo. The logo is white text on a blue background. The text is in all capital letters and is slightly slanted.
0
510(k) Premarket Notification - Traditional
| Feature | Name |
|---|---|
| --------- | ------ |
IPE, Image Post-processing Engine
6. Predicate Devices
| Predicate Devices | |||||||
|---|---|---|---|---|---|---|---|
| #1 | #2 | #3 | #4 | #5 | #6 | #7 | |
| Device | |||||||
| Name | GC70 | GU60A&GU6 | |||||
| 0A-65 | GF50 | GF50A | GR40C | ||||
| W | GM85 | GC85A | |||||
| Classificati | |||||||
| on Name | Stationa | ||||||
| ry X-ray | |||||||
| System | Stationary X- | ||||||
| ray System | Stationa | ||||||
| ry X-ray | |||||||
| System | Stationa | ||||||
| ry X-ray | |||||||
| System | Solid | ||||||
| State X- | |||||||
| ray | |||||||
| Imager | Mobile | ||||||
| X-ray | |||||||
| System | Stationa | ||||||
| ry X-ray | |||||||
| System | |||||||
| Product | |||||||
| Code | KPR | KPR | KPR | KPR | MQB | IZL | KPR |
| Regulation | 21 CFR | ||||||
| 892.168 | |||||||
| 0 | 21 CFR | ||||||
| 892.1680 | 21 CFR | ||||||
| 892.168 | |||||||
| 0 | 21 CFR | ||||||
| 892.168 | |||||||
| 0 | 21 CFR | ||||||
| 892.168 | |||||||
| 0 | 21 CFR | ||||||
| 892.17 | |||||||
| 20 | 21 CFR | ||||||
| 892.168 | |||||||
| 0 | |||||||
| 510(K)# | K16311 | ||||||
| 5 | K173828 | K14032 | |||||
| 6 | K15141 | ||||||
| 9 | K15340 | ||||||
| 1 | K17111 | ||||||
| 9 | K17222 | ||||||
| 9 | |||||||
| 510(K) | |||||||
| Decision | |||||||
| Date | Dec., | ||||||
| 07, | |||||||
| 2016 | Jan., 12, 2018 | May, 29, | |||||
| 2014 | Jun., | ||||||
| 23, | |||||||
| 2015 | Dec., | ||||||
| 21, | |||||||
| 2015 | May, | ||||||
| 12, | |||||||
| 2017 | Nov., | ||||||
| 22, | |||||||
| 2017 |
7. Device Description
GC70, GU60&GU60A-65, GF50, GF50A, GR40CW and GM85 are 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.
An IPE operates, from the input image, the roles of a region-of-interest extraction, tonescale mapping, noise reduction and texture restoration. The IPE employing an advanced noise reduction algorithm is shown that the image quality of PA radiograph for average adult chest, exposed at the condition of 50% lower dose at Entrance Skin Exposure (ESE) in comparison with the condition of the conventional noise reduction algorithm, is substantially equivalent. It was cleared with K172229 that using the IPE is able to reduce dose of 50% for chest PA of average adult in GC85A.
This submission is purposed to get 510(k) clearance for expanding the scope of the claim, cleared with K172229, from GC85A to the proposed devices, Samsung x-ray systems.
The IPE, a software which has no relation with imaging chain, is applied to the proposed devices and it is evaluated that images acquired by a various imaging chain are
10
Image /page/10/Picture/1 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold letters. The word is inside of a blue, rounded, oval shape.
510(k) Premarket Notification - Traditional
substantially equivalent to GC85A in a non-clinical evaluation.
The proposed devices with the IPE employing an advanced noise reduction algorithm are able to reduce dose of 50% for chest PA of average adult for marketing purpose.
This claim is based on a limited study of an anthropomorphic phantom that simulates the x-ray properties of an average size adult, and on a small clinical study at one facility. Only routine PA chest radiography was studied, and results for larger-size adults (body mass index) greater than 30 was not studied to statistical significance. The pediatric patients was not studied and the clinical site is responsible for determining whether the particular radiographic imaging needs are not impacted by such x-ray dose reduction.
8. Intended Use
The GC70 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 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.
GF50 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 GF50A 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 GR40CW Digital X-ray Imaging System is intended for use in general projection radiographic applications wherever conventional screen-film systems or CR systems may be used. This device is not intended for mammographic applications.
The GM85 Digital Mobile X-ray imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
9. Summary of Technological characteristic of the proposed devices compared with the predicate devices
The proposed devices, GC70, GU60&GU60A-65, GF50, GF50A, GR40CW and GM85, apply the IPE with employing an advanced noise reduction algorithm, which was cleared with K172229, to GC70, GU60&GU60A-65, GF50, GF50A, GR40CW and GM85 products which were cleared with respectively K163115, K173828, K140326, K151419, K153401 and K171119 without changes in technical characteristics.
There is identical and nothing changed in technological characteristic between the predicate and proposed devices.
11
Image /page/11/Picture/1 description: The image shows the Samsung logo. The logo is in a blue rounded rectangle with the word "SAMSUNG" in white letters. The letters are bold and sans-serif.
510(k) Premarket Notification - Traditional
A. Compared with Predicate Devices
| Specification | Proposed Device #1 | Predicate Device #7 | Discussion | |
|---|---|---|---|---|
| Device Name | GC70 | GC85A | ||
| Manufacturer | SAMSUNG ELECTRONICS Co., Ltd. | SAMSUNG ELECTRONICS Co., Ltd. | ||
| 510(k) Number | None | K172229 | ||
| Intended Use | The GC70 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 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 | |
| High Voltage Generator | ||||
| Type | High Frequency | High Frequency | Same as PD#1 | |
| Max. Power | 82kW | 82kW | Same as PD#1 | |
| Tube Voltage | 40-150kV | 40-150kV | Same as PD#1 | |
| Output RANGE | Tube Current | 10-1000mA | 10-1000mA | Same as PD#1 |
| Exposure Time | 1msec-10sec | 1msec-10sec | Same as PD#1 | |
| AEC (Automatic Exposure Control) | Yes | Same as PD#1 | ||
| APR (Anatomically Programmed Radiography) | Yes | Same as PD#1 | ||
| X-ray tube | ||||
| Name | E7869X | E7869X | Same as PD#1 | |
| kV range | 40-150kV | 40-150kV | Same as PD#1 | |
| Max. Power | Large focus | 100kW | 100kW | Same as PD#1 |
| Small focus | 40kW | 40kW | Same as PD#1 | |
| Max. mA | Large focus | 1000mA | 1000mA | Same as PD#1 |
| Small focus | 500mA | 500mA | Same as PD#1 | |
| Anode target material | Rhenium-Tungsten | Rhenium-Tungsten | Same as PD#1 |
12
Image /page/12/Picture/1 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold letters. The word is placed on a blue, oval-shaped background.
| Collimator | |||||||
|---|---|---|---|---|---|---|---|
| Name | SDR-OGCL83U | SDR-OGCL80U | SDR-OGCL83U | Same as PD#1 | |||
| Overall | |||||||
| Size(mm) | H212 X W306 | ||||||
| X D179 | H212 X | ||||||
| W300 | |||||||
| X D179 | H212 X | ||||||
| W306 | |||||||
| X D179 | Same as PD#1 | ||||||
| Beam Limiting | |||||||
| Blade | |||||||
| Moving Method | Motorized | ||||||
| /Manual | Motorized | ||||||
| /Manual | Motorized | ||||||
| /Manual | Same as PD#1 | ||||||
| Manual | |||||||
| Operation | |||||||
| Method | Volume | Volume | Volume | Same as PD#1 | |||
| Collimator | |||||||
| Rotation | ±45 | ±45 | ±45 | Same as PD#1 | |||
| Beam Light | |||||||
| Source | LED | LED | LED | Same as PD#1 | |||
| Light Field | |||||||
| Indicator Timer | O | O | O | Same as PD#1 | |||
| O | O | O | Same as PD#1 | ||||
| Side Lamp | Laser Module | Laser | |||||
| Module | Laser | ||||||
| Module | Same as PD#1 | ||||||
| Field Size / SID | |||||||
| Display | Color LCD | Color | |||||
| LCD | Color | ||||||
| LCD | Same as PD#1 | ||||||
| Detector | |||||||
| Name | S433 | ||||||
| 5-W | S434 | ||||||
| 3-W | S302 | ||||||
| 5-W | S433 | ||||||
| 5-W | S434 | ||||||
| 3-W | S302 | ||||||
| 5-W | Same as PD#1 | ||||||
| Csl | Csl | Csl | Csl | Csl | Csl | Same as PD#1 | |
| Detector Type | Indire | ||||||
| ct | Indire | ||||||
| ct | Indire | ||||||
| ct | Indire | ||||||
| ct | Indire | ||||||
| ct | Indire | ||||||
| ct | Same as PD#1 | ||||||
| Detector Area | 14"X1 | ||||||
| 7" | |||||||
| (345 | |||||||
| mmX | |||||||
| 425m | |||||||
| m) | 17"X1 | ||||||
| 7" | |||||||
| (425 | |||||||
| mmX | |||||||
| 425m | |||||||
| m) | 10"X1 | ||||||
| 2" | |||||||
| (245 | |||||||
| mmX | |||||||
| 295m | |||||||
| m) | 14"X1 | ||||||
| 7" | |||||||
| (345 | |||||||
| mmX | |||||||
| 425m | |||||||
| m) | 17"X1 | ||||||
| 7" | |||||||
| (425 | |||||||
| mmX | |||||||
| 425m | |||||||
| m) | 10"X1 | ||||||
| 2" | |||||||
| (245 | |||||||
| mmX | |||||||
| 295m | |||||||
| m) | Same as PD#1 | ||||||
| Number of | |||||||
| pixels | 2466 | ||||||
| X304 | |||||||
| 0 | 3036 | ||||||
| X304 | |||||||
| 0 | 1750 | ||||||
| X210 | |||||||
| 8 | 2466 | ||||||
| X304 | |||||||
| 0 | 3036 | ||||||
| X304 | |||||||
| 0 | 1750 | ||||||
| X210 | |||||||
| 8 | Same as PD#1 | ||||||
| Pixel Pitch(um) | 140 | 140 | 140 | 140 | 140 | 140 | Same as PD#1 |
| High Contrast | |||||||
| Limiting | |||||||
| Resolution | |||||||
| (LP/mm) | 3.57 | 3.57 | 3.57 | 3.57 | 3.57 | 3.57 | Same as PD#1 |
| Communication | Wired | ||||||
| / | |||||||
| Wirel | |||||||
| ess | Wired | ||||||
| / | |||||||
| Wirel | |||||||
| ess | Wired | ||||||
| / | |||||||
| Wirel | |||||||
| ess | Wired | ||||||
| / | |||||||
| Wirel | |||||||
| ess | Wired | ||||||
| / | |||||||
| Wirel | |||||||
| ess | Wired | ||||||
| / | |||||||
| Wirel | |||||||
| ess | Same as PD#1 | ||||||
| Image Post-processing Engine | |||||||
| Noise reduction | |||||||
| algorithm | Image Post-processing Engine | ||||||
| with an advanced | Same as PD#7 |
13
Image /page/13/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.
| | noise reduction
algorithm | noise reduction
algorithm | |
| -- | ------------------------------ | ------------------------------ | -- |
|---|
| Specification | Proposed Device #2 | Predicate Device #7 | Discussion | ||
|---|---|---|---|---|---|
| GU60A | GU60A-65 | ||||
| Device Name | GU60A & GU60A-65 | GC85A | |||
| Manufacturer | SAMSUNG | ||||
| ELECTRONICS | |||||
| Ltd. | Co., | SAMSUNG | |||
| ELECTRONICS | |||||
| Co., | |||||
| Ltd. | |||||
| 510(k) Number | None | K172229 | |||
| 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 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#2 | ||||
| High Voltage Generator | |||||
| Type | High Frequency | High Frequency | Same as PD#2 | ||
| Max. Power | 50kW/68kW | 65kW | 82kW | Same as PD#2 | |
| Tube | |||||
| Voltage | 40 to | ||||
| 150kVp | 40 to | ||||
| 150kVp | 40-150kV | Same as PD#2 | |||
| Output | |||||
| RANGE | Tube | ||||
| Current | 10 - | ||||
| 630mA/ | |||||
| 10 - | |||||
| 800mA | 10 - | ||||
| 800mA | 10-1000mA | Same as PD#2 | |||
| Exposure | |||||
| Time | 1msec- | ||||
| 6.3sec/ | |||||
| 1msec- | |||||
| 10sec | 1msec- | ||||
| 6.3sec | 1msec-10sec | Same as PD#2 | |||
| X-ray tube | |||||
| Name | |||||
| kV range | E7252X | ||||
| 40-150kV | E7869X | ||||
| 40-150kV | Same as PD#2 | ||||
| Max. | |||||
| Power | Large | ||||
| focus | 75kW | 100kW | Same as PD#2 | ||
| Small | |||||
| focus | 27kW | 40kW | Same as PD#2 | ||
| Max. | |||||
| mA | Large | ||||
| focus | 1000mA | 1000mA | Same as PD#2 | ||
| Small | |||||
| focus | 400mA | 500mA | Same as PD#2 | ||
| Anode target | |||||
| material | Rhenium-Tungsten | Rhenium-Tungsten | Same as PD#2 | ||
| Collimator |
14
Image /page/14/Picture/1 description: The image features the SAMSUNG logo. The logo is displayed in white text against a blue background. The text is bold and slightly italicized.
| Name | SDR-OGCL82U | SDR-OGCL80
U | SDR-OGCL83
U | Same as PD#2 | | | |
|----------------------------------------------------|--------------------------------------------------------------------------------------|------------------------------------------|------------------------------------------|--------------------------------------------------------------------------------------|------------------------------------------|------------------------------------------|--------------|
| Overall
Size(mm) | H212 X W306
X D179 | H212 X
W300
X D179 | H212 X
W306
X D179 | Same as PD#2 | | | |
| Beam Limiting
Blade
Moving Method | Motorized
/Manual | Motorized
/Manual | Motorized
/Manual | Same as PD#2 | | | |
| Manual
Operation
Method | Volume | Volume | Volume | Same as PD#2 | | | |
| Collimator
Rotation | ±45 | ±45 | ±45 | Same as PD#2 | | | |
| Beam Light
Source | LED | LED | LED | Same as PD#2 | | | |
| Light Field
Indicator Timer | O | O | O | Same as PD#2 | | | |
| Side Lamp | Laser Module | Laser
Module | Laser
Module | Same as PD#2 | | | |
| Field Size / SID
Display | Color LCD | Color
LCD | Color
LCD | Same as PD#2 | | | |
| Detector | | | | | | | |
| Name | S433
5-W | S434
3-W | S302
5-W | S433
5-W | S434
3-W | S302
5-W | Same as PD#2 |
| | Csl | Csl | Csl | Csl | Csl | Csl | Same as PD#2 |
| Detector Type | Indire
ct | Indire
ct | Indire
ct | Indire
ct | Indire
ct | Indire
ct | Same as PD#2 |
| Detector Area | 14"X
17"
(345
mmX
425m
m) | 17"X
17"
(425
mmX
425m
m) | 10"X1
2"
(245
mmX
295m
m) | 14"X
17"
(345
mmX
425m
m) | 17"X1
7"
(425
mmX
425m
m) | 10"X1
2"
(245
mmX
295m
m) | Same as PD#2 |
| Number of
pixels | 2466
X304
0 | 3036
X304
0 | 1750
X210
8 | 2466
X304
0 | 3036
X304
0 | 1750
X210
8 | Same as PD#2 |
| Pixel Pitch(um) | 140 | 140 | 140 | 140 | 140 | 140 | Same as PD#2 |
| High Contrast
Limiting
Resolution
(LP/mm) | 3.57 | 3.57 | 3.57 | 3.57 | 3.57 | 3.57 | Same as PD#2 |
| Communication | Wired/
Wirel
ess | Wired/
Wirel
ess | Wired/
Wirel
ess | Wired/
Wirel
ess | Wired/
Wirel
ess | Wired/
Wirel
ess | Same as PD#2 |
| 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 | | | Same as PD#7 |
15
Image /page/15/Picture/1 description: The image shows the Samsung logo. The logo is in a blue oval shape. The word "SAMSUNG" is written in white, bold letters inside the oval.
| Specification | Proposed Device #3 | Predicate Device #7 | Discussion | |
|---|---|---|---|---|
| Device Name | GF50 | GC85A | ||
| Manufacturer | SAMSUNG | |||
| ELECTRONICS Co., | ||||
| Ltd. | SAMSUNG | |||
| ELECTRONICS Co., | ||||
| Ltd. | ||||
| 510(k) Number | None | K172229 | ||
| Intended Use | The GF50 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 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#3 | |||
| High Voltage Generator | ||||
| Type | High Frequency | High Frequency | Same as PD#3 | |
| Max. Power | 52kW | 82kW | Same as PD#3 | |
| Output | ||||
| RANGE | Tube | |||
| Voltage | ||||
| 40-150kV | Tube | |||
| Voltage | ||||
| 40-150kV | Same as PD#3 | |||
| Tube | ||||
| Current | ||||
| 10-640mA | Tube | |||
| Current | ||||
| 10-1000mA | Same as PD#3 | |||
| Exposure | ||||
| Time | ||||
| 1msec-10sec | Exposure | |||
| Time | ||||
| 1msec-10sec | Same as PD#3 | |||
| AEC | ||||
| (Automatic | ||||
| Exposure | ||||
| Control) | Yes | Yes | Same as PD#3 | |
| APR | ||||
| (Anatomically | ||||
| Programmed | ||||
| Radiography) | Yes | Yes | Same as PD#3 | |
| X-ray tube | ||||
| Name | E7252X | E7869X | Same as PD#3 | |
| kV range | 40-150kV | 40-150kV | Same as PD#3 | |
| Max. | ||||
| Power | Large focus | 75kW | 100kW | Same as PD#3 |
| Small focus | 27kW | 40kW | Same as PD#3 | |
| Max. | ||||
| mA | Large focus | 1000mA | 1000mA | Same as PD#3 |
| Small focus | 400mA | 500mA | Same as PD#3 | |
| Anode target | ||||
| material | Rhenium-Tungsten | Rhenium-Tungsten | Same as PD#3 |
16
Image /page/16/Picture/1 description: The image features the word "SAMSUNG" in bold, white letters against a blue, rounded rectangular background. The font is sans-serif and the letters are evenly spaced. The blue background has a slight gradient, with the color appearing darker towards the edges.
| Collimator | |||||
|---|---|---|---|---|---|
| Name | SDR-OGCL50D | SDR-OGCL80U | SDR-OGCL83U | Same as PD#3 | |
| Overall | |||||
| Size(mm) | H185 X W213 | ||||
| X D180 | H212 X W300 | ||||
| X D179 | H212 X W306 | ||||
| X D179 | Same as PD#3 | ||||
| Beam Limiting | |||||
| Blade | |||||
| Moving Method | Manual | Motorized /Manual | Motorized /Manual | Same as PD#3 | |
| Manual | |||||
| Operation | |||||
| Method | Volume | Volume | Volume | Same as PD#3 | |
| Collimator | |||||
| Rotation | $\pm 45$ | $\pm 45$ | $\pm 45$ | Same as PD#3 | |
| Beam Light | |||||
| Source | Halogen Lamp | LED | LED | Same as PD#3 | |
| Light Field | |||||
| Indicator Timer | O | O | O | Same as PD#3 | |
| O | O | O | Same as PD#3 | ||
| Side Lamp | Laser Module | Laser Module | Laser Module | Same as PD#3 | |
| Field Size / SID | |||||
| Display | Color LCD | Color LCD | Color LCD | Same as PD#3 | |
| Detector | |||||
| Name | S4335-W | S433 5-W | S434 3-W | S302 5-W | Same as PD#3 |
| Csl | Csl | Csl | Csl | Same as PD#3 | |
| Detector Type | Indirect | Indirect | Indirect | Indirect | Same as PD#3 |
| Detector Area | 14"X17" | ||||
| (345mmX425mm) | 14"X 17" | ||||
| (345 mmX 425m m) | 17"X 17" | ||||
| (425 mmX 425m m) | 10"X 12" | ||||
| (245 mmX 295m m) | Same as PD#3 | ||||
| Number of | |||||
| pixels | 2466X3040 | 2466 X304 0 | 3036 X304 0 | 1750 X210 8 | Same as PD#3 |
| Pixel Pitch(um) | 140 | 140 | 140 | 140 | Same as PD#3 |
| High Contrast | |||||
| Limiting | |||||
| Resolution | |||||
| (LP/mm) | 3.5 | 3.57 | 3.57 | 3.57 | Same as PD#3 |
| Communication | Wired / Wireless | Wired / Wirel ess | Wired / Wirel ess | Wired / Wirel ess | Same as PD#3 |
| Image Post-processing Engine | |||||
| Noise reduction | |||||
| algorithm | Image Post- | ||||
| processing Engine | |||||
| with an advanced | Image Post- | ||||
| processing Engine | |||||
| with an advanced | Same as PD#7 | ||||
| noise reduction | |||||
| algorithm | noise reduction | ||||
| algorithm | noise reduction | ||||
| algorithm |
17
Image /page/17/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.
| Specification | Proposed Device #4 | Predicate Device #7 | Discussion | ||
|---|---|---|---|---|---|
| Device Name | GF50A | ||||
| SAMSUNG | |||||
| ELECTRONICS Co., | |||||
| Ltd. | GC85A | ||||
| SAMSUNG | |||||
| ELECTRONICS Co., | |||||
| Ltd. | |||||
| 510(k) Number | None | K172229 | |||
| Intended Use | The GF50A 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 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#4 | ||||
| High Voltage Generator | |||||
| Type | High Frequency | High Frequency | Same as PD#4 | ||
| Max. Power | 40kW | 82kW | Same as PD#4 | ||
| Output | |||||
| RANGE | Tube | ||||
| Voltage | 40-125kV | 40-150kV | Same as PD#4 | ||
| Tube | |||||
| Current | 10-500mA | 10-1000mA | Same as PD#4 | ||
| Exposure | |||||
| Time | 1msec-10sec | 1msec-10sec | Same as PD#4 | ||
| AEC | |||||
| (Automatic | |||||
| Exposure | |||||
| Control) | Yes | Yes | Same as PD#4 | ||
| APR | |||||
| (Anatomically | |||||
| Programmed | |||||
| Radiography) | Yes | Yes | Same as PD#4 | ||
| X-ray tube | |||||
| Name | E7252X | E7869X | Same as PD#3 | ||
| kV range | 40-150kV | 40-150kV | Same as PD#3 | ||
| Max. | |||||
| Power | Large focus | 75kW | 100kW | Same as PD#3 | |
| Small focus | 27kW | 40kW | Same as PD#3 | ||
| Max. | |||||
| mA | Large focus | 1000mA | 1000mA | Same as PD#3 | |
| Small focus | 400mA | 500mA | Same as PD#3 | ||
| Anode target | |||||
| material | Rhenium-Tungsten | Rhenium-Tungsten | Rhenium-Tungsten | Same as PD#3 | |
| Collimator | |||||
| Name | SDR-OGCL50D | SDR-OGCL80 | |||
| U | SDR-OGCL83 | ||||
| U | Same as PD#4 | ||||
| Overall | |||||
| Size(mm) | H185 X W213 | ||||
| X D180 | H212 X | ||||
| W300 | |||||
| X D179 | H212 X | ||||
| W306 | |||||
| X D179 | Same as PD#4 | ||||
| Beam Limiting | |||||
| Blade | |||||
| Moving Method | Manual | Motorized | |||
| /Manual | Motorized | ||||
| /Manual | Same as PD#4 | ||||
| Manual | |||||
| Operation | |||||
| Method | Volume | Volume | Volume | Same as PD#4 | |
| Collimator | |||||
| Rotation | +90 | ±45 | ±45 | Same as PD#4 | |
| Beam Light | |||||
| Source | Halogen Lamp | LED | LED | Same as PD#4 | |
| Light Field | |||||
| Indicator Timer | O | O | O | Same as PD#4 | |
| O | O | O | Same as PD#4 | ||
| Side Lamp | Laser Module | Laser | |||
| Module | Laser | ||||
| Module | Same as PD#4 | ||||
| Field Size / SID | |||||
| Display | Color LCD | Color | |||
| LCD | Color | ||||
| LCD | Same as PD#4 | ||||
| Detector | |||||
| Name | S4335-W | S433 | |||
| 5-W | S434 | ||||
| 3-W | S302 | ||||
| 5-W | |||||
| Csl | Csl | Csl | Csl | Same as PD#4 | |
| Detector Type | Indirect | Indire | |||
| ct | Indire | ||||
| ct | Indire | ||||
| ct | Same as PD#4 | ||||
| Detector Area | 14"X17" | ||||
| (345mmX425mm) | 14"X | ||||
| 17" | |||||
| (345 | |||||
| mmX | |||||
| 425m | |||||
| m) | 17"X | ||||
| 17" | |||||
| (425 | |||||
| mmX | |||||
| 425m | |||||
| m) | 10"X | ||||
| 12" | |||||
| (245 | |||||
| mmX | |||||
| 295m | |||||
| m) | Same as PD#4 | ||||
| Number of | |||||
| pixels | 2466X3040 | 2466 | |||
| X304 | |||||
| 0 | 3036 | ||||
| X304 | |||||
| 0 | 1750 | ||||
| X210 | |||||
| 8 | Same as PD#4 | ||||
| Pixel Pitch(um) | 140 | 140 | 140 | 140 | Same as PD#4 |
| High Contrast | |||||
| Limiting | |||||
| Resolution | |||||
| (LP/mm) | 3.5 | 3.57 | 3.57 | 3.57 | Same as PD#4 |
| Communication | Wired / Wireless | Wired / | |||
| Wirel | |||||
| ess | Wired / | ||||
| Wirel | |||||
| ess | Wired / | ||||
| Wirel | |||||
| ess | Same as PD#4 |
18
Image /page/18/Picture/1 description: The image shows the SAMSUNG logo. The logo is white text on a blue oval background. The text is in a bold, sans-serif font.
19
Image /page/19/Picture/1 description: The image shows the word "SAMSUNG" in white letters against a blue background. The word is written in a bold, sans-serif font. The blue background is a solid color, and the white letters stand out clearly against it.
| Noise reduction
algorithm | Image Post-
processing Engine
with an advanced
noise reduction
algorithm | Image Post-
processing Engine
with an advanced
noise reduction
algorithm | Same as PD#7 |
| ------------------------------ | -------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------- | -------------- |
|---|
| Specification | Proposed Device #5 | Predicate Device #7 | Discussion | |||||
|---|---|---|---|---|---|---|---|---|
| Device Name | GR40CW | GC85A | ||||||
| Manufacturer | SAMSUNG | |||||||
| ELECTRONICS Co., | ||||||||
| Ltd. | SAMSUNG | |||||||
| ELECTRONICS Co., | ||||||||
| Ltd. | ||||||||
| 510(k) Number | None | K172229 | ||||||
| Intended Use | The GR40CW Digital | |||||||
| X-ray Imaging System | ||||||||
| is intended for use in | ||||||||
| general projection | ||||||||
| radiographic | ||||||||
| applications wherever | ||||||||
| conventional screen- | ||||||||
| film systems or CR | ||||||||
| systems may be used. | ||||||||
| 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#5 | |||||||
| Detector | ||||||||
| Name | S43 | |||||||
| 35- | ||||||||
| W | S43 | |||||||
| 35- | ||||||||
| WV | S43 | |||||||
| 43- | ||||||||
| W | S30 | |||||||
| 25- | ||||||||
| W | S433 | |||||||
| 5-W | S434 | |||||||
| 3-W | S302 | |||||||
| 5-W | Same as PD#5 | |||||||
| Detector Type | Csl | $Gd2O2S$ | Csl | Csl | Csl | Csl | Csl | Same as PD#5 |
| Indi | ||||||||
| rect | Indi | |||||||
| rect | Indi | |||||||
| rect | Indi | |||||||
| rect | Indire | |||||||
| ct | Indire | |||||||
| ct | Indire | |||||||
| ct | Same as PD#5 | |||||||
| Detector Area | 14" | |||||||
| X17 | ||||||||
| "(3 | ||||||||
| 45 | ||||||||
| mm | ||||||||
| X42 | ||||||||
| 5m | ||||||||
| m) | 14" | |||||||
| X17 | ||||||||
| "(34 | ||||||||
| 5m | ||||||||
| mX | ||||||||
| 425 | ||||||||
| mm | ||||||||
| ) | 17" | |||||||
| X17 | ||||||||
| "(42 | ||||||||
| 5m | ||||||||
| mX | ||||||||
| 425 | ||||||||
| mm | ||||||||
| ) | 10" | |||||||
| X12 | ||||||||
| "(24 | ||||||||
| 5m | ||||||||
| mX | ||||||||
| 295 | ||||||||
| mm | ||||||||
| ) | 14"X | |||||||
| 17" | ||||||||
| (345 | ||||||||
| mmX | ||||||||
| 425m | ||||||||
| m) | 17"X | |||||||
| 17" | ||||||||
| (425 | ||||||||
| mmX | ||||||||
| 425m | ||||||||
| m) | 10"X | |||||||
| 12" | ||||||||
| (245 | ||||||||
| mmX | ||||||||
| 295m | ||||||||
| m) | Same as PD#5 | |||||||
| Number of | ||||||||
| pixels | 246 | |||||||
| 6X3 | ||||||||
| 040 | 246 | |||||||
| 6X3 | ||||||||
| 040 | 303 | |||||||
| 6X3 | ||||||||
| 040 | 175 | |||||||
| 0X2 | ||||||||
| 108 | 2466 | |||||||
| X304 | ||||||||
| 0 | 3036 | |||||||
| X304 | ||||||||
| 0 | 1750 | |||||||
| X210 | ||||||||
| 8 | Same as PD#5 | |||||||
| Pixel Pitch(um) | 140 | 140 | 140 | 140 | 140 | 140 | 140 | Same as PD#5 |
| High Contrast | ||||||||
| Limiting | ||||||||
| Resolution | ||||||||
| (LP/mm) | 3.57 | 3.5 | 3.57 | 3.57 | 3.57 | 3.57 | 3.57 | Same as PD#5 |
| Communication | Wir | Wir | Wir | Wir | Wired | Wired | Wired | Same as PD#5 |
20
Image /page/20/Picture/1 description: The image features the SAMSUNG logo. The logo is displayed in white text against a blue background. The text is bold and sans-serif.
| | ed /
Wir
ele
ss | ed /
Wir
ele
ss | ed /
Wir
ele
ss | ed /
Wir
ele
ss | /
Wirel
ess | /
Wirel
ess | /
Wirel
ess |
|------------------------------|--------------------------|--------------------------------------------------------------------------------------|--------------------------|--------------------------------------------------------------------------------------|-------------------|-------------------|-------------------|
| 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 | Same as PD#7 | | |
| Specification | Proposed Device #6 | Predicate Device #7 | Discussion | |
|---|---|---|---|---|
| Device Name | GM85 | GC85A | ||
| Manufacturer | SAMSUNG | |||
| ELECTRONICS Co., | ||||
| Ltd. | SAMSUNG | |||
| ELECTRONICS Co., | ||||
| Ltd. | ||||
| 510(k) Number | None | K172229 | ||
| Intended Use | The GM85 Digital | |||
| Mobile X-ray imaging | ||||
| System is intended for | ||||
| use in generating | ||||
| radiographic images | ||||
| of human anatomy by | ||||
| a qualified/trained | ||||
| doctor or technician. | ||||
| This device is not | ||||
| intended for | ||||
| mammographic | ||||
| applications. | The 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#6 | |||
| High Voltage Generator | ||||
| Type | High Frequency | High Frequency | Same as PD#6 | |
| Max. Power | 32kW / 40kW | 82kW | Same as PD#6 | |
| Tube | ||||
| Voltage | 40 to 150kVp | 40-150kV | Same as PD#6 | |
| Output | ||||
| RANGE | Tube | |||
| Current | 10 - 500mA | 10-1000mA | Same as PD#6 | |
| Exposure | ||||
| Time | 1msec-10sec | 1msec-10sec | Same as PD#6 | |
| AEC | ||||
| (Automatic | ||||
| Exposure | ||||
| Control) | No | Yes | Same as PD#6 | |
| APR | ||||
| (Anatomically | ||||
| Programmed | ||||
| Radiography) | Yes | Yes | Same as PD#6 | |
| X-ray tube | ||||
| Name | XRR- | |||
| 3332X | LUC-13L | E7869X | Same as PD#6 |
21
Image /page/21/Picture/1 description: The image shows the word "SAMSUNG" in white letters against a blue background. The font is bold and sans-serif. The logo is simple and modern.
| kV range | 40-150kV | 40-150kV | 40-150kV | Same as PD#6 | |
|---|---|---|---|---|---|
| Max. Powe r | Large focus | 46kW | 45kW | 100kW | Same as PD#6 |
| Small focus | 20kW | 19kW | 40kW | Same as PD#6 | |
| Max. mA | Large focus | 600mA | 600mA | 1000mA | Same as PD#6 |
| Small focus | 300mA | 260mA | 500mA | Same as PD#6 | |
| Anode target material | Rhenium-Tungsten | Rhenium-Tungsten | Rhenium-Tungsten | Same as PD#6 | |
| Collimator | |||||
| Name | SDR-OGCL40U | SDR-OGCL80 U | SDR-OGCL83 U | Same as PD#6 | |
| Overall Size(mm) | H212 X W306 X D179 | H212 X W300 X D179 | H212 X W306 X D179 | Same as PD#6 | |
| Beam Limiting Blade Moving Method | Motorized /Manual | Motorized /Manual | Motorized /Manual | Same as PD#6 | |
| Manual Operation Method | Volume | Volume | Volume | Same as PD#6 | |
| Collimator Rotation | +90/-180 | $\pm$ 45 | $\pm$ 45 | Same as PD#6 | |
| Beam Light Source | LED | LED | LED | Same as PD#6 | |
| Light Field Indicator Timer | O | O | O | Same as PD#6 | |
| Side Lamp | Laser Module | Laser Module | Laser Module | Same as PD#6 | |
| Field Size / SID Display | Color LCD | Color LCD | Color LCD | Same as PD#6 | |
| Detector | |||||
| Name | S433 5-W | S434 3-W | S302 5-W | Same as PD#6 | |
| Csl | Csl | Csl | Same as PD#6 | ||
| Detector Type | Indirect | Indirect | Indirect | Same as PD#6 | |
| Detector Area | 14"X 17" (345 mmX 425m m) | 17"X 17" (425 mmX 425m m) | 10"X1 2" (245 mmX 295m m) | Same as PD#6 | |
| Number of pixels | 2466 X304 0 | 3036 X304 0 | 1750 X210 8 | Same as PD#6 | |
| Pixel Pitch(um) | 140 | 140 | 140 | Same as PD#6 | |
| High Contrast | 3.57 | 3.57 | 3.57 | Same as PD#6 |
22
Image /page/22/Picture/1 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white, bold letters. The word is set against a blue, oval-shaped background.
510(k) Premarket Notification - Traditional
| Limiting
Resolution
| (LP/mm) | |||||||
|---|---|---|---|---|---|---|---|
| Communication | Wired | ||||||
| / | |||||||
| Wirel | |||||||
| ess | Wired | ||||||
| / | |||||||
| Wirel | |||||||
| ess | Wired | ||||||
| / | |||||||
| Wirel | |||||||
| ess | Wired | ||||||
| / | |||||||
| Wirel | |||||||
| ess | Wired | ||||||
| / | |||||||
| Wirel | |||||||
| ess | Wired | ||||||
| / | |||||||
| Wirel | |||||||
| ess | Same as PD#6 | ||||||
| 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 | Same as PD#7 |
10. Safety and EMC
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 verified followed by guidance, Radio frequency Wireless Technology in Medical Devices. All test results were satisfying the standards.
11. Verification of Software and Non-clinical data
The quantitative assessment of image quality was conducted with the images of TOR CDR radiography phantom and TO20 contrast detail phantom taken at a various exposure condition with different Samsung X-ray imaging systems. Modulation Transfer Function (MTF), Contrast to Noise (CNR) and visibility of the images were measured and compared. As a result of comparison, the image quality produced at the same dose level by different Samsung was same. This testing shows that the image quality produced by the subject devices and predicate GC85A are substantially equivalent when used at the same dose levels. Therefore, the IPE is capable of providing the same dose reduction in AP adult chest radiographs for the proposed devices as it does for the predicate GC85A.
12. Clinical data
This submission does not required clinical data.
13. Conclusions
The non-clinical data demonstrates that the IPE in the proposed devices, operating not depending on Samsung digital x-ray systems, is as safe, as effective, and performs as well as the legally marketed predicate devices.