(84 days)
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.
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 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.
The provided text is a 510(k) Premarket Notification summary for several Samsung Digital X-ray Imaging Systems (GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85). The core of the submission is to expand the scope of a previously cleared Image Post-processing Engine (IPE) with an advanced noise reduction algorithm (from K172229 for GC85A) to these additional devices, claiming that the IPE can achieve a 50% dose reduction for chest PA of average adults while maintaining image quality.
However, the document explicitly states: "This submission does not required clinical data." This means that a clinical study proving the device meets specific acceptance criteria based on human reader performance with or without AI (MRMC study) was not conducted or submitted as part of this premarket notification. The evaluation relies heavily on non-clinical data and the substantial equivalence to a predicate device that previously demonstrated the dose reduction claim for a specific device (GC85A).
Given this, I cannot provide a table of acceptance criteria based on a clinical study or details about a MRMC study, as none were required or performed for this specific submission's scope expansion.
Here's what can be extracted and inferred from the document regarding the device and its testing, tailored to the questions where information is available:
Acceptance Criteria and Device Performance (Based on Non-Clinical Data)
Since no clinical study was required for this submission, the "acceptance criteria" and "reported device performance" are based on non-clinical evaluations comparing the image quality of the proposed devices with the IPE to the predicate device (GC85A) and to images produced with conventional settings. The primary claim revolves around the ability to maintain image quality at a 50% reduced dose.
Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)
| Acceptance Criterion (Non-Clinical) | Reported Device Performance (Non-Clinical) |
|---|---|
| Image Quality Equivalence at Same Dose: Image quality produced by the subject devices (with IPE) at the same dose level must be substantially equivalent to the predicate device (GC85A) at the same dose level. | "As a result of comparison [of MTF, CNR, and visibility], 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." |
| Dose Reduction Claim: The IPE (Image Post-processing Engine) should enable a 50% dose reduction for chest PA of average adult while maintaining image quality. (This claim was previously cleared for the predicate GC85A). | "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." "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." |
| Safety and EMC Standards Compliance: Electrical, mechanical, environmental safety, and EMC testing according to relevant standards. | "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." |
Study Details (Based on Available Information)
-
Sample sized used for the test set and the data provenance:
- Test Set (Non-clinical): The document mentions "a limited study of an anthropomorphic phantom that simulates the x-ray properties of an average size adult" and "a small clinical study at one facility." However, the quantitative assessment for this specific submission's purpose (expanding IPE scope) was non-clinical: "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." No specific sample size (number of phantom images) is provided.
- Data Provenance: The anthropomorphic phantom study and "small clinical study" mentioned for the initial GC85A clearance (K172229) are noted as having limitations: "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..." The origin country of the data is not explicitly stated for these studies, but Samsung is a Republic of Korea company. The non-clinical test set for this submission involved "various Samsung X-ray imaging systems" which would likely be internally generated. The studies mentioned (phantom and small clinical) for the original IPE clearance (K172229) were likely a mix of retrospective/prospective, but this detail is not provided for those underlying studies, nor are they claimed as part of this current submission's direct evidence, only referenced as a basis.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For the non-clinical quantitative assessment in this submission (MTF, CNR, visibility of phantom images), human experts were not used to establish quantitative ground truth. These are objective measures.
- For the original clearance of the IPE (K172229) where the "small clinical study" and "substantially equivalent" image quality claim was made with 50% dose reduction based on human perception, no details about expert readers, their number, or qualifications are provided in this summary.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for the non-clinical quantitative assessment of phantom images.
- Not provided for the underlying "small clinical study" that was part of the original IPE clearance.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. The document explicitly states: "This submission does not required clinical data." Therefore, no MRMC comparative effectiveness study was performed or submitted for this specific 510(k) notification. The evaluation relies on substantial equivalence to the predicate and non-clinical data.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The IPE is a software component (algorithm) that processes images. The "quantitative assessment of image quality was conducted with the images of TOR CDR radiography phantom and TO20 contrast detail phantom," which constitutes a standalone (algorithm only) performance evaluation based on objective image quality metrics (MTF, CNR, visibility). This confirms the algorithm's ability to process images in a way that, quantitatively, maintains image quality.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical quantitative assessment (of image quality parameters like MTF, CNR, visibility), the "ground truth" is derived from physical phantoms with known properties and objective measurements. It is not based on expert consensus, pathology, or outcomes data.
- The claim of "substantially equivalent" image quality at 50% dose reduction (from K172229) implicitly relies on human perception from a "small clinical study," but the ground truth establishment method for that is not detailed here.
-
The sample size for the training set:
- Not mentioned in the document. The document describes the "proposed devices" (SAMSUNG X-ray systems) and the "IPE" (Image Post-processing Engine) as software. It asserts that the IPE "operates, from the input image, the roles of a region-of-interest extraction, tonescale mapping, noise reduction and texture restoration." It also notes the IPE "employing an advanced noise reduction algorithm." While algorithms require training data, the submission does not delve into the development or training of the IPE.
-
How the ground truth for the training set was established:
- Not mentioned in the document, as details about the IPE's development and training process are outside the scope of this 510(k) summary, which focuses on demonstrating substantial equivalence for the application of an already cleared IPE to new devices.
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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
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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 | |
| TradeName | GC70 | GU60A&GU60A-65 | GF50 | GF50A | GR40CW | GM85 |
| DeviceName | GC70 | GU60A&GU60A-65 | GF50 | GF50A | GR40CW | GM85 |
| CommonName | DigitalDiagnostic X-raySystem | DigitalDiagnostic X-ray System | DigitalDiagnostic X-raySystem | DigitalDiagnostic X-raySystem | RetrofitKit | DigitalDiagnostic MobileX-raySystem |
| Classification Name | StationaryX-raySystem | Stationary X-ray System | StationaryX-raySystem | StationaryX-raySystem | SolidState X-rayImager | Mobile X-raySystem |
| ProductCode | KPR | KPR | KPR | KPR | MQB | IZL |
| Regulation | 21 CFR892.1680 | 21 CFR892.1680 | 21 CFR892.1680 | 21 CFR892.1680 | 21 CFR892.168 | 21 CFR892.1720 |
{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 | |
| DeviceName | GC70 | GU60A&GU60A-65 | GF50 | GF50A | GR40CW | GM85 | GC85A |
| Classification Name | Stationary X-raySystem | Stationary X-ray System | Stationary X-raySystem | Stationary X-raySystem | SolidState X-rayImager | MobileX-raySystem | Stationary X-raySystem |
| ProductCode | KPR | KPR | KPR | KPR | MQB | IZL | KPR |
| Regulation | 21 CFR892.1680 | 21 CFR892.1680 | 21 CFR892.1680 | 21 CFR892.1680 | 21 CFR892.1680 | 21 CFR892.1720 | 21 CFR892.1680 |
| 510(K)# | K163115 | K173828 | K140326 | K151419 | K153401 | K171119 | K172229 |
| 510(K)DecisionDate | 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.
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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 | |||
| OverallSize(mm) | H212 X W306X D179 | H212 XW300X D179 | H212 XW306X D179 | Same as PD#1 | |||
| Beam LimitingBladeMoving Method | Motorized/Manual | Motorized/Manual | Motorized/Manual | Same as PD#1 | |||
| ManualOperationMethod | Volume | Volume | Volume | Same as PD#1 | |||
| CollimatorRotation | ±45 | ±45 | ±45 | Same as PD#1 | |||
| Beam LightSource | LED | LED | LED | Same as PD#1 | |||
| Light FieldIndicator Timer | O | O | O | Same as PD#1 | |||
| O | O | O | Same as PD#1 | ||||
| Side Lamp | Laser Module | LaserModule | LaserModule | Same as PD#1 | |||
| Field Size / SIDDisplay | Color LCD | ColorLCD | ColorLCD | Same as PD#1 | |||
| Detector | |||||||
| Name | S4335-W | S4343-W | S3025-W | S4335-W | S4343-W | S3025-W | Same as PD#1 |
| Csl | Csl | Csl | Csl | Csl | Csl | Same as PD#1 | |
| Detector Type | Indirect | Indirect | Indirect | Indirect | Indirect | Indirect | Same as PD#1 |
| Detector Area | 14"X17"(345mmX425mm) | 17"X17"(425mmX425mm) | 10"X12"(245mmX295mm) | 14"X17"(345mmX425mm) | 17"X17"(425mmX425mm) | 10"X12"(245mmX295mm) | Same as PD#1 |
| Number ofpixels | 2466X3040 | 3036X3040 | 1750X2108 | 2466X3040 | 3036X3040 | 1750X2108 | Same as PD#1 |
| Pixel Pitch(um) | 140 | 140 | 140 | 140 | 140 | 140 | Same as PD#1 |
| High ContrastLimitingResolution(LP/mm) | 3.57 | 3.57 | 3.57 | 3.57 | 3.57 | 3.57 | Same as PD#1 |
| Communication | Wired/Wireless | Wired/Wireless | Wired/Wireless | Wired/Wireless | Wired/Wireless | Wired/Wireless | Same as PD#1 |
| Image Post-processing Engine | |||||||
| Noise reductionalgorithm | Image Post-processing Enginewith 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 reductionalgorithm | noise reductionalgorithm | ||
|---|---|---|---|
| -- | ------------------------------ | ------------------------------ | -- |
| Specification | Proposed Device #2 | Predicate Device #7 | Discussion | ||
|---|---|---|---|---|---|
| GU60A | GU60A-65 | ||||
| Device Name | GU60A & GU60A-65 | GC85A | |||
| Manufacturer | SAMSUNGELECTRONICSLtd. | Co., | SAMSUNGELECTRONICSCo.,Ltd. | ||
| 510(k) Number | None | K172229 | |||
| Intended Use | The GU60A &GU60A-65 Digital X-ray Imaging Systemsare intended for use ingeneratingradiographic imagesof human anatomy bya qualified/traineddoctor or technician.This device is notintended formammographicapplications. | The GC85A Digital X-ray Imaging System isintended for use ingeneratingradiographic imagesof human anatomy bya qualified/traineddoctor or technician.This device is notintended formammographicapplications. | 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 | |
| TubeVoltage | 40 to150kVp | 40 to150kVp | 40-150kV | Same as PD#2 | |
| OutputRANGE | TubeCurrent | 10 -630mA/10 -800mA | 10 -800mA | 10-1000mA | Same as PD#2 |
| ExposureTime | 1msec-6.3sec/1msec-10sec | 1msec-6.3sec | 1msec-10sec | Same as PD#2 | |
| X-ray tube | |||||
| NamekV range | E7252X40-150kV | E7869X40-150kV | Same as PD#2 | ||
| Max.Power | Largefocus | 75kW | 100kW | Same as PD#2 | |
| Smallfocus | 27kW | 40kW | Same as PD#2 | ||
| Max.mA | Largefocus | 1000mA | 1000mA | Same as PD#2 | |
| Smallfocus | 400mA | 500mA | Same as PD#2 | ||
| Anode targetmaterial | 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-OGCL80U | SDR-OGCL83U | Same as PD#2 | |||
|---|---|---|---|---|---|---|---|
| OverallSize(mm) | H212 X W306X D179 | H212 XW300X D179 | H212 XW306X D179 | Same as PD#2 | |||
| Beam LimitingBladeMoving Method | Motorized/Manual | Motorized/Manual | Motorized/Manual | Same as PD#2 | |||
| ManualOperationMethod | Volume | Volume | Volume | Same as PD#2 | |||
| CollimatorRotation | ±45 | ±45 | ±45 | Same as PD#2 | |||
| Beam LightSource | LED | LED | LED | Same as PD#2 | |||
| Light FieldIndicator Timer | O | O | O | Same as PD#2 | |||
| Side Lamp | Laser Module | LaserModule | LaserModule | Same as PD#2 | |||
| Field Size / SIDDisplay | Color LCD | ColorLCD | ColorLCD | Same as PD#2 | |||
| Detector | |||||||
| Name | S4335-W | S4343-W | S3025-W | S4335-W | S4343-W | S3025-W | Same as PD#2 |
| Csl | Csl | Csl | Csl | Csl | Csl | Same as PD#2 | |
| Detector Type | Indirect | Indirect | Indirect | Indirect | Indirect | Indirect | Same as PD#2 |
| Detector Area | 14"X17"(345mmX425mm) | 17"X17"(425mmX425mm) | 10"X12"(245mmX295mm) | 14"X17"(345mmX425mm) | 17"X17"(425mmX425mm) | 10"X12"(245mmX295mm) | Same as PD#2 |
| Number ofpixels | 2466X3040 | 3036X3040 | 1750X2108 | 2466X3040 | 3036X3040 | 1750X2108 | Same as PD#2 |
| Pixel Pitch(um) | 140 | 140 | 140 | 140 | 140 | 140 | Same as PD#2 |
| High ContrastLimitingResolution(LP/mm) | 3.57 | 3.57 | 3.57 | 3.57 | 3.57 | 3.57 | Same as PD#2 |
| Communication | Wired/Wireless | Wired/Wireless | Wired/Wireless | Wired/Wireless | Wired/Wireless | Wired/Wireless | Same as PD#2 |
| Image Post-processing Engine | |||||||
| Noise reductionalgorithm | Image Post-processing Enginewith an advancednoise reductionalgorithm | Image Post-processing Enginewith an advancednoise reductionalgorithm | 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 | SAMSUNGELECTRONICS Co.,Ltd. | SAMSUNGELECTRONICS Co.,Ltd. | ||
| 510(k) Number | None | K172229 | ||
| Intended Use | The GF50 Digital X-ray Imaging System isintended for use ingeneratingradiographic imagesof human anatomy bya qualified/traineddoctor or technician.This device is notintended formammographicapplications. | The GC85A Digital X-ray Imaging System isintended for use ingeneratingradiographic imagesof human anatomy bya qualified/traineddoctor or technician.This device is notintended formammographicapplications. | Same as PD#3 | |
| High Voltage Generator | ||||
| Type | High Frequency | High Frequency | Same as PD#3 | |
| Max. Power | 52kW | 82kW | Same as PD#3 | |
| OutputRANGE | TubeVoltage40-150kV | TubeVoltage40-150kV | Same as PD#3 | |
| TubeCurrent10-640mA | TubeCurrent10-1000mA | Same as PD#3 | ||
| ExposureTime1msec-10sec | ExposureTime1msec-10sec | Same as PD#3 | ||
| AEC(AutomaticExposureControl) | Yes | Yes | Same as PD#3 | |
| APR(AnatomicallyProgrammedRadiography) | 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 targetmaterial | 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 | |
| OverallSize(mm) | H185 X W213X D180 | H212 X W300X D179 | H212 X W306X D179 | Same as PD#3 | |
| Beam LimitingBladeMoving Method | Manual | Motorized /Manual | Motorized /Manual | Same as PD#3 | |
| ManualOperationMethod | Volume | Volume | Volume | Same as PD#3 | |
| CollimatorRotation | $\pm 45$ | $\pm 45$ | $\pm 45$ | Same as PD#3 | |
| Beam LightSource | Halogen Lamp | LED | LED | Same as PD#3 | |
| Light FieldIndicator 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 / SIDDisplay | 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 ofpixels | 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 ContrastLimitingResolution(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 reductionalgorithm | Image Post-processing Enginewith an advanced | Image Post-processing Enginewith an advanced | Same as PD#7 | ||
| noise reductionalgorithm | noise reductionalgorithm | noise reductionalgorithm |
{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 | GF50ASAMSUNGELECTRONICS Co.,Ltd. | GC85ASAMSUNGELECTRONICS Co.,Ltd. | |||
| 510(k) Number | None | K172229 | |||
| Intended Use | The GF50A Digital X-ray Imaging System isintended for use ingeneratingradiographic imagesof human anatomy bya qualified/traineddoctor or technician.This device is notintended formammographicapplications. | The GC85A Digital X-ray Imaging System isintended for use ingeneratingradiographic imagesof human anatomy bya qualified/traineddoctor or technician.This device is notintended formammographicapplications. | Same as PD#4 | ||
| High Voltage Generator | |||||
| Type | High Frequency | High Frequency | Same as PD#4 | ||
| Max. Power | 40kW | 82kW | Same as PD#4 | ||
| OutputRANGE | TubeVoltage | 40-125kV | 40-150kV | Same as PD#4 | |
| TubeCurrent | 10-500mA | 10-1000mA | Same as PD#4 | ||
| ExposureTime | 1msec-10sec | 1msec-10sec | Same as PD#4 | ||
| AEC(AutomaticExposureControl) | Yes | Yes | Same as PD#4 | ||
| APR(AnatomicallyProgrammedRadiography) | 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 targetmaterial | Rhenium-Tungsten | Rhenium-Tungsten | Rhenium-Tungsten | Same as PD#3 | |
| Collimator | |||||
| Name | SDR-OGCL50D | SDR-OGCL80U | SDR-OGCL83U | Same as PD#4 | |
| OverallSize(mm) | H185 X W213X D180 | H212 XW300X D179 | H212 XW306X D179 | Same as PD#4 | |
| Beam LimitingBladeMoving Method | Manual | Motorized/Manual | Motorized/Manual | Same as PD#4 | |
| ManualOperationMethod | Volume | Volume | Volume | Same as PD#4 | |
| CollimatorRotation | +90 | ±45 | ±45 | Same as PD#4 | |
| Beam LightSource | Halogen Lamp | LED | LED | Same as PD#4 | |
| Light FieldIndicator Timer | O | O | O | Same as PD#4 | |
| O | O | O | Same as PD#4 | ||
| Side Lamp | Laser Module | LaserModule | LaserModule | Same as PD#4 | |
| Field Size / SIDDisplay | Color LCD | ColorLCD | ColorLCD | Same as PD#4 | |
| Detector | |||||
| Name | S4335-W | S4335-W | S4343-W | S3025-W | |
| Csl | Csl | Csl | Csl | Same as PD#4 | |
| Detector Type | Indirect | Indirect | Indirect | Indirect | Same as PD#4 |
| Detector Area | 14"X17"(345mmX425mm) | 14"X17"(345mmX425mm) | 17"X17"(425mmX425mm) | 10"X12"(245mmX295mm) | Same as PD#4 |
| Number ofpixels | 2466X3040 | 2466X3040 | 3036X3040 | 1750X2108 | Same as PD#4 |
| Pixel Pitch(um) | 140 | 140 | 140 | 140 | Same as PD#4 |
| High ContrastLimitingResolution(LP/mm) | 3.5 | 3.57 | 3.57 | 3.57 | Same as PD#4 |
| Communication | Wired / Wireless | Wired /Wireless | Wired /Wireless | Wired /Wireless | 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 reductionalgorithm | Image Post-processing Enginewith an advancednoise reductionalgorithm | Image Post-processing Enginewith an advancednoise reductionalgorithm | Same as PD#7 |
|---|---|---|---|
| ------------------------------ | -------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------- | -------------- |
| Specification | Proposed Device #5 | Predicate Device #7 | Discussion | |||||
|---|---|---|---|---|---|---|---|---|
| Device Name | GR40CW | GC85A | ||||||
| Manufacturer | SAMSUNGELECTRONICS Co.,Ltd. | SAMSUNGELECTRONICS Co.,Ltd. | ||||||
| 510(k) Number | None | K172229 | ||||||
| Intended Use | The GR40CW DigitalX-ray Imaging Systemis intended for use ingeneral projectionradiographicapplications whereverconventional screen-film systems or CRsystems may be used.This device is notintended formammographicapplications. | The GC85A Digital X-ray Imaging System isintended for use ingeneratingradiographic imagesof human anatomy bya qualified/traineddoctor or technician.This device is notintended formammographicapplications. | Same as PD#5 | |||||
| Detector | ||||||||
| Name | S4335-W | S4335-WV | S4343-W | S3025-W | S4335-W | S4343-W | S3025-W | Same as PD#5 |
| Detector Type | Csl | $Gd2O2S$ | Csl | Csl | Csl | Csl | Csl | Same as PD#5 |
| Indirect | Indirect | Indirect | Indirect | Indirect | Indirect | Indirect | Same as PD#5 | |
| Detector Area | 14"X17"(345mmX425mm) | 14"X17"(345mmX425mm) | 17"X17"(425mmX425mm) | 10"X12"(245mmX295mm) | 14"X17"(345mmX425mm) | 17"X17"(425mmX425mm) | 10"X12"(245mmX295mm) | Same as PD#5 |
| Number ofpixels | 2466X3040 | 2466X3040 | 3036X3040 | 1750X2108 | 2466X3040 | 3036X3040 | 1750X2108 | Same as PD#5 |
| Pixel Pitch(um) | 140 | 140 | 140 | 140 | 140 | 140 | 140 | Same as PD#5 |
| High ContrastLimitingResolution(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 /Wireless | ed /Wireless | ed /Wireless | ed /Wireless | /Wireless | /Wireless | /Wireless | |
|---|---|---|---|---|---|---|---|
| Image Post-processing Engine | |||||||
| Noise reductionalgorithm | Image Post-processing Enginewith an advancednoise reductionalgorithm | Image Post-processing Enginewith an advancednoise reductionalgorithm | Same as PD#7 |
| Specification | Proposed Device #6 | Predicate Device #7 | Discussion | |
|---|---|---|---|---|
| Device Name | GM85 | GC85A | ||
| Manufacturer | SAMSUNGELECTRONICS Co.,Ltd. | SAMSUNGELECTRONICS Co.,Ltd. | ||
| 510(k) Number | None | K172229 | ||
| Intended Use | The GM85 DigitalMobile X-ray imagingSystem is intended foruse in generatingradiographic imagesof human anatomy bya qualified/traineddoctor or technician.This device is notintended formammographicapplications. | The GC85A Digital X-ray Imaging System isintended for use ingeneratingradiographic imagesof human anatomy bya qualified/traineddoctor or technician.This device is notintended formammographicapplications. | 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 | |
| TubeVoltage | 40 to 150kVp | 40-150kV | Same as PD#6 | |
| OutputRANGE | TubeCurrent | 10 - 500mA | 10-1000mA | Same as PD#6 |
| ExposureTime | 1msec-10sec | 1msec-10sec | Same as PD#6 | |
| AEC(AutomaticExposureControl) | No | Yes | Same as PD#6 | |
| APR(AnatomicallyProgrammedRadiography) | 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
| LimitingResolution(LP/mm) | |||||||
|---|---|---|---|---|---|---|---|
| Communication | Wired/Wireless | Wired/Wireless | Wired/Wireless | Wired/Wireless | Wired/Wireless | Wired/Wireless | Same as PD#6 |
| Image Post-processing Engine | |||||||
| Noise reductionalgorithm | Image Post-processing Enginewith an advancednoise reductionalgorithm | Image Post-processing Enginewith an advancednoise reductionalgorithm | 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.
§ 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.