(66 days)
Not Found
No
The document describes a standard digital X-ray imaging system and its components. There is no mention of AI, ML, or any related technologies in the intended use, device description, or performance studies. The image processing described is standard digital conversion and amplification.
No
This device is an X-ray imaging system, used for diagnosis by generating radiographic images, not for therapy.
No
The device is described as an X-ray imaging system that generates radiographic images. While these images are used by doctors for diagnosis, the device itself is focused on image acquisition and processing rather than directly performing a diagnosis or providing diagnostic interpretations. Its purpose is to produce images that are then "used for reading images" by a qualified professional.
No
The device description explicitly lists numerous hardware components (High voltage generator, X-ray tube, Detector, etc.) that are integral to the device's function. While it includes software (S-Station), it is part of a larger hardware system.
Based on the provided information, the GC85A Digital X-ray Imaging System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens taken from the human body. The intended use of the GC85A is to generate radiographic images of human anatomy by transmitting X-rays through the patient's body. This is an in vivo (within the living body) process, not an in vitro (in glass, or outside the living body) process.
- The device description clearly outlines the components and process of capturing X-ray images of a patient. It describes the interaction of X-rays with the patient's body and the subsequent processing of the signals to create an image. This is consistent with diagnostic imaging, not laboratory testing of specimens.
Therefore, the GC85A Digital X-ray Imaging System falls under the category of medical imaging devices, not IVD devices.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
KPR
Device Description
The GC85A digital X-ray imaging system consists of High voltage generator (HVG), Ceiling Suspension, X-ray tube, Collimator, Detector, AEC, DAP, CIB(Control Interface Box), Wall Stand, Patient Table, Collimator, Detector, Remote controller, Grid, Foot switch, Barcode scanner and Auto-stitching stand.
This system is used to capture images by transmitting X-ray to a patient's body.
The X-ray passing through a patient's body is sent to the detector and then converted into electrical signals. These signals go through the process of amplification and digital data conversion in the signal process device before being sent to the S-Station (Operation Software) and saved in DICOM file, a standard for medical imaging. The captured images are sent to the Picture Archiving & Communication System (PACS) server, and can be used for reading images.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Digital X-ray
Anatomical Site
human anatomy
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified/trained doctor or technician.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical data: The proposed detectors show curves and measurements of MTF and DQE that do not differ from the predicate device.
Clinical data: Clinical images were obtained in accordance with FDA guidance for the submission of 510(k)'s for Solid State X-ray Imaging Devices. They were evaluated by a professional radiologist and found to be equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 2, 2015
Samsung Electronics Co., Ltd. % Chulsin Kim Regulatory Affairs Manager 129, Samsung-ro, Yeongtong-gu Suwon-si, Gyeonggi-do 443-742 REPUBLIC OF KOREA
Re: K150165
Trade/Device Name: GC85A Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: January 23, 2015 Received: January 26, 2015
Dear Chulsin Kim:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Robert A Ochs
Robert Ochs. Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name GC85A
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/1 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white, bold, sans-serif font. The word is set against a blue, oval-shaped background that is tilted slightly. The logo is simple and modern, and it is easily recognizable.
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: January 23, 2015
-
- Submitter
- Company Name: SAMSUNG ELECTRONICS Co., Ltd. A.
- B. Address: 129, Samsung-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do, 443-742, Republic of Korea
3. Primary Contact Person
- A. Name: KIM, CHULSIN
- B. Title: Regulatory Affairs Manager
- C. Phone Number: +82-31-200-7661
- FAX Number: +82-31-200-1199 D. E-Mail: chulsin.kim@samsung.com
4. Secondary Contact Person
- Name: Ninad Gujar A.
- B. Title: Regulatory Affairs Manager
- C. Phone Number: 978-564-8503
- D. FAX Number: 978-750-6677 E-Mail: ngujar@samsungneurologica.com
5. Proposed Device
- A. Trade Name: GC85A
- B. Device Name: GC85A
- C. Common Name: Digital Diagnostic X-ray System
- Classification Name: System, X-ray, Stationary D.
- Product Code: KPR ட்.
- F. Regulation: 21 CFR 892.1680
6. Predicate Device
- A. Manufacturer: SAMSUNG ELECTRONICS Co., Ltd.
- B. Trade Name: XGEO GC80
- C. Classification Name: System, X-ray, Stationary
- D. Product Code: KPR
- E. 510(k) Number: K140334
- 510(k) Decision Date: May 28, 2014 F.
7. Device Description
The GC85A digital X-ray imaging system consists of High voltage generator (HVG), Ceiling
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Image /page/4/Picture/1 description: The image shows the Samsung logo. The word "SAMSUNG" is written in white, bold, sans-serif font. The text is set against a blue, rounded, rectangular background.
510(k) Premarket Notification - Traditional
Suspension, X-ray tube, Collimator, Detector, AEC, DAP, CIB(Control Interface Box), Wall Stand, Patient Table, Collimator, Detector, Remote controller, Grid, Foot switch, Barcode scanner and Auto-stitching stand.
This system is used to capture images by transmitting X-ray to a patient's body.
The X-ray passing through a patient's body is sent to the detector and then converted into electrical signals. These signals go through the process of amplification and digital data conversion in the signal process device before being sent to the S-Station (Operation Software) and saved in DICOM file, a standard for medical imaging. The captured images are sent to the Picture Archiving & Communication System (PACS) server, and can be used for reading images.
8. Intended Use
The 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.
9. Summary of Technological characteristic of the proposed device compared with the predicate device
The proposed GC85A adds new detectors and modify wall stand to the predicate device, and it does not have significant change in materials, energy source or technological characteristics compared to the predicate device, XGEO GC80 (K140334). Comparisons of the following technological characteristics were assessed and the results demonstrate the substantial equivalence to the predicates.
| Specification | Predicate Device | Proposed Device | Discussion |
|---|---|---|---|
| Device Name | XGEO GC80 | GC85A | |
| Manufacturer | SAMSUNG ELECTRONICS | SAMSUNG ELECTRONICS | |
| 510(k) Number | K140334 | N/A | |
| Appearances | Same | ||
| Intended Use | The XGEO GC80 digital X-ray | The GC85A digital X-ray | Same |
| imaging system is intended for | imaging system is intended for | ||
| use in generating radiographic | use in generating radiographic | ||
| images of human anatomy by a | images of human anatomy by | ||
| qualified/trained doctor or | a qualified/trained doctor or | ||
| technician. This device is not | technician. This device is not | ||
| intended for mammographic | intended for mammographic | ||
| applications. | applications. |
| Manufacturer Contents | XGEO GC80 (K140334) | GC85A | Discussion |
|---|---|---|---|
| ----------------------- | --------------------- | ------- | ------------ |
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Image /page/5/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 angled.
510(k) Premarket Notification - Traditional
| Manufacturer Contents | XGEO GC80 (K140334) | GC85A | Discussion | |
|---|---|---|---|---|
| (1)High Voltage Generator | ||||
| Type | High Frequency | High Frequency | Same | |
| Max. Power | 80kW | 82kW | Difference(1) | |
| Output | ||||
| RANGE | Tube Voltage | 40-150kV | 40-150kV | Same |
| Tube Current | 10-1000mA | 10-1000mA | Same | |
| Exposure | ||||
| Time | 1msec-6.3sec | 1msec-10sec | Difference(2) | |
| AEC | ||||
| (Automatic Exposure Control) | Yes | Yes | ||
| APR (Anatomically | ||||
| Programmed Radiography) | Yes | Yes | Same |
| Manufacturer Contents | XGEO GC80 (K140334) | GC85A | Discussion | |
|---|---|---|---|---|
| (2)Ceiling Suspension | ||||
| Moving | ||||
| Range | ||||
| (mm) | Longitudinal | 1680~4180 | ||
| (Varies with room size) | 1680~4180 | |||
| (Varies with room | ||||
| size) | Same | |||
| Lateral | 1030~3030 | |||
| (Varies with room size) | 1030~3030 | |||
| (Varies with room | ||||
| size) | Same | |||
| Vertical | 1840 | 1800 | Difference(3) | |
| Vertical Tube Moving method | Motorized | Motorized | Same | |
| Tube Assembly Rotation | -157 ~ +183 | -157 ~ +183 | Same | |
| Brake locking Method | Electromagnetic | Electromagnetic | Same | |
| Automatic Centering | O | O | Same | |
| Moving Rail Type | Al Extrusion | Al Extrusion | Same | |
| Image Preview | O | O | Same | |
| Display Type | Color LCD | Color LCD | Same | |
| Control Switch Type | Button |
- Touch Screen | Button
- Touch Screen | Same |
| | With Table | O | O | Same |
| Vertical Sync. | With Stand | O | O | Same |
| Manufacturer Contents | XGEO GC80 (K140334) | GC85A | Discussion | ||
|---|---|---|---|---|---|
| (3) Wall Stand | |||||
| Vertical | |||||
| Movement | Mechanism | Motorized/Manual | Motorized | Difference(4) | |
| Range(mm) | 400~1800 | 280~1850 | Difference(5) | ||
| Detector/tube servo coupling | Yes | Yes | Same | ||
| Detector | Tilting | Mechanism | Motorized | Motorized | Same |
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Image /page/6/Picture/1 description: The image shows the SAMSUNG logo in white text on a blue background. The logo is stylized with a slightly italicized font. The blue background is in the shape of an oval.
510(k) Premarket Notification - Traditional
| Manufacturer Contents | XGEO GC80 (K140334) | GC85A | Discussion | |
|---|---|---|---|---|
| Range | -20~+90 | -20~+90 | Same | |
| AEC | Conventional | Conventional | Same | |
| Grid | Lines/cm | 84.6 | 85/92 | Difference(6) |
| Grid mechanism | Stationary | Stationary | Same | |
| Removability | Removable | Removable | Same | |
| Detector Support Mounting | Floor | Floor | Same | |
| Patient Support Device | Patient handgrips, lateral support bar | Patient handgrips, lateral support bar | Same |
| Manufacturer Contents | XGEO GC80 (K140334) | GC85A | Discussion | ||
|---|---|---|---|---|---|
| (4)Patient Table | |||||
| Table Top | Size(mm) | 2410 X 812 | 2410 X 812 | Same | |
| Rang | Lateral | ±140 | ±140 | Same | |
| e | |||||
| (mm) | Longitudi | ||||
| nal | +480 | +480 | Same | ||
| Table height | Mechanism | DC Motor, Ball screw | DC Motor, Ball screw | Same | |
| Range(mm) | 545 ~ 900 | 545 ~ 900 | Same | ||
| Horizontal range of detector(mm) | 590 | 688 | Difference(7) | ||
| AEC | Conventional | Conventional | Same | ||
| Grid | Lines/cm | 84.6 | 85/92 | Difference(8) | |
| Grid mechanism | Stationary | Stationary | Same | ||
| Removability | Removable | Removable | Same | ||
| Vertical Sync. | O | O | Same | ||
| Control Switch Type | Foot switch | Foot switch | Same | ||
| Maximum Patient Weight(kg) | 350 | ||||
| (Static, Center load) | 350 | ||||
| (Static, Center load) | Same |
| Manufacturer Contents | XGEO GC80 (K140334) | GC85A | Discussion |
|---|---|---|---|
| (5)Collimator | |||
| Overall Size(mm) | H212 X W300 | ||
| X D179 | H212 X W300 | ||
| X D179 | Same | ||
| Beam Limiting Blade | |||
| Moving Method | Motorized | ||
| /Manual | Motorized | ||
| /Manual | Same | ||
| Manual Operation Method | Volume | Volume | Same |
| Collimator Rotation | ±45 | ±45 | Same |
| Beam Light Source | LED | LED | Same |
| Light Field Indicator Timer | O | O | Same |
| Side Lamp | O | O | Same |
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Image /page/7/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 recognizable, and the blue color is a signature of the brand.
510(k) Premarket Notification - Traditional
| Manufacturer Contents | XGEO GC80 (K140334) | GC85A | Discussion |
|---|---|---|---|
| Laser Module | Laser Module | Same | |
| Field Size / SID Display | Color LCD | Color LCD | Same |
| Manufacturer
| Contents | XGEO GC80 (K140334) | GC85A | Discussion | |||
|---|---|---|---|---|---|---|
| (6) Detector | ||||||
| *NOTE: S4335-W, S4343-W were cleared with K140334. | ||||||
| Name | S4335-W | S4343-W | S4335-W | S4343-W | S3025-W | |
| Detector Type | CsI | CsI | CsI | CsI | CsI | Same |
| Indirect | Indirect | Indirect | Indirect | Indirect | Same | |
| Detector Area | 14"X17" | |||||
| (345mmX42 | ||||||
| 5mm) | 17"X17" | |||||
| (425mmX42 | ||||||
| 5mm) | 14"X17" | |||||
| (345mmX42 | ||||||
| 5mm) | 17"X17" | |||||
| (425mmX42 | ||||||
| 5mm) | 10"X12" | |||||
| (245mmX29 | ||||||
| 5mm) | Difference(9) | |||||
| Number of pixels | 2466X3040 | 3036X3040 | 2466X3040 | 3036X3040 | 1750X2108 | |
| Pixel Pitch(um) | 140 | 140 | 140 | 140 | 140 | |
| High Contrast | ||||||
| Limiting | ||||||
| Resolution | ||||||
| (LP/mm) | 3.57 | 3.57 | 3.57 | 3.57 | 3.57 | Difference |
| (10) | ||||||
| Communication | Wired / | |||||
| Wireless | Wired / | |||||
| Wireless | Wired / | |||||
| Wireless | Wired / | |||||
| Wireless | Wired / | |||||
| Wireless | Same |
| No | Differences | Explanation |
|---|---|---|
| (1) | HVG Max Power | Proposed medical device's HVG has higher max power than the predicate device's max power, and the higher max power does not contribute any adverse impacts to the device's safety and performance. |
| (2) | HVG Exposure Time Range | Proposed medical device's HVG maximum exposure time longer than the predicate device's one, and the longer exposure time does not contribute any adverse impacts to the device's safety and performance. |
| (3) | Vertical moving range of Ceiling Suspension | Proposed medical device's Vertical moving range of Ceiling Suspension has shorter than the predicate device's moving range, but the shorter moving range does not contribute any adverse impacts to the device's safety and performance. |
| (4) | Vertical Movement Mechanism of Wall Stand | Proposed medical device's Vertical Movement Mechanism of Wall Stand has a motorized method, while the predicate device's Vertical Movement Mechanism of Wall Stand has two methods as manual & motorized. The movement mechanism does not contribute any adverse impacts to the device's safety and performance. |
| (5) | Vertical Moving range of | Proposed medical device's Vertical Moving range of Wall Stand has |
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Image /page/8/Picture/1 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white, set against a blue, rounded rectangular background. The font is sans-serif and bold, giving the logo a clean and modern appearance. The blue background provides a strong contrast, making the white text stand out.
510(k) Premarket Notification - Traditional
| | Wall Stand | longer than the predicate device's one, and the longer moving range
does not contribute any adverse impacts to the device's safety and
performance. |
|------|---------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| (6) | Grid line ( Wall stand ) | Proposed medical device's Line Pair of Grid installed in Wall Stand
has higher than the predicate device's one, and the higher line pair of
grid does not contribute any adverse impacts to the device's safety
and performance. |
| (7) | Horizontal range of
detector (Patient Table) | Proposed medical device's Horizontal Moving range of Detector
installed Patient Table has longer than the predicate device's one,
and the longer moving range does not contribute any adverse impacts
to the device's safety and performance. |
| (8) | Grid line (Patient Table) | Proposed medical device's Line Pair of Grid installed in Patient Table
has higher than the predicate device's one, and the higher line pair of
grid does not contribute any adverse impacts to the device's safety
and performance. |
| (9) | Detector Area | Proposed medical device's S3025-W detector has smaller area than
the predicate device's detectors while technical specification is
identical among them such as type & pixel pitch, and the smaller area
does not contribute any adverse impacts to the device's safety and
performance. |
| (10) | Number of pixels
Resolution and pixel pitch
of detector | Proposed medical device's S3025-W detector has smaller detector
area. Therefore, the proposed medical device's numbers of pixels is
smaller than the predicate device's detectors while pixel pitch is
identical among them, and the smaller number of pixels does not
contribute any adverse impacts to the device's safety and
performance. |
In non-clinical data, the proposed detectors show curves and measurements of MTF and DQE that do not differ from the predicate device. In clinical data, the proposed GC85A has been shown a substantially equivalent to the predicate device.
10. Safety, EMC and Performance Data
Electrical, mechanical, environmental safety and performance testing according to standard ES 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-28, IEC 60601-2-54, ISO14971, 21CFR1020.30 and 21CFR1020.31 were performed, and EMC testing was 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. Non-clinical data
Non-clinical testing data was provided in conformance to the FDA "Guidance for the Submission of 510(k)'s for Solid-State X-ray Imaging Devices", which includes MTF and DQE measurements as tested by IEC 62220-1. The proposed device shows no difference in non-clinical testing data such as MTF and DQE measurements from the predicate device.
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Image /page/9/Picture/1 description: The image shows the Samsung logo. The logo consists of the word "SAMSUNG" in white, sans-serif font, set against a blue, elliptical background. The ellipse is tilted slightly, giving the logo a dynamic appearance.
510(k) Premarket Notification - Traditional
12. Clinical data
In clinical data, clinical images were obtained in accordance with FDA guidance for the submission of 510(k)'s for Solid State X-ray Imaging Devices. They were evaluated by a professional radiologist and found to be equivalent to the predicate device.
13. Conclusions
Clinical images were provided; these images were not necessary to establish substantial equivalence based on the modifications to the device but they provide further evidence in addition to the laboratory performance data to show that the complete system works as intended. These images were evaluated by a radiologist with equivalent U.S. board certification and found to be equivalent to the predicate device.
-
- Samsung Electronics Co., Ltd. will update and include in this summary any other information deemed seasonably necessary by the FDA