(31 days)
Not Found
No
The summary describes standard digital X-ray technology with image acquisition, processing, and display capabilities. There is no mention of AI, ML, or related concepts, nor are there descriptions of training or test sets typically associated with AI/ML development.
No.
The device is described as a "Digital X-ray Capture Device" used for acquiring and displaying radiographic images, which is a diagnostic function, not a therapeutic one. It replaces film/screen systems in diagnostic procedures.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures (excluding fluoroscopic, angiographic, and mammographic applications)." This indicates its role in obtaining images for diagnostic purposes.
No
The device description explicitly states that the system includes a digital detector (flat panel detector), X-ray generator interface, and image acquisition hardware, in addition to the operation workstation software. This indicates it is a hardware and software system, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "general radiographic images of human anatomy" and to "replace radiographic film/screen systems in all general-purpose diagnostic procedures". This describes a device used for imaging the body, not for performing tests on samples taken from the body (like blood, urine, tissue, etc.).
- Device Description: The description focuses on the components and function of an X-ray imaging system (digital detector, X-ray generator interface, image acquisition, workstation, etc.). It does not mention any components or processes related to analyzing biological samples.
- Input Imaging Modality: The input is X-ray, which is an imaging modality, not a method for analyzing biological samples.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is clearly an imaging device used to visualize internal structures.
N/A
Intended Use / Indications for Use
The Saturn 8000 system generates digital X-ray images that can be used for general X-ray system except fluoroscopic, angiographic, and mammographic applications. The Saturn 8000 system can interface to any X-ray generator and get digital X-ray image. The Saturn 8000 is intended to be used in same clinical application as traditional film-screen based general radiography system.
The Digital X-ray Capture Device Saturn 8000 Systems is indicated for use in general radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures (excluding fluoroscopic, angiographic, and mammographic applications).
Product codes
MQB
Device Description
The "Digital X-ray Capture Device (Saturn 8000 System)" (as Saturn 8000 System) is equipped with digital detector. X-ray generator interface, and image acquisition. The digital detector is a flat panel detector. The input X-ray photons are absorbed in scintillator layer that creates a visible light photon, and then the photon is absorbed in TFT-array to create an electrical charge which is representation of the X-ray inout. The charge is read-out by a matrix scan of the array that converts the charges into a modulated electrical signal. Interfacing with generator can be achieved by Automatic Exposure Detection ("AED") technology which allows detector to automatically detects X-ray exposure. The Saturn 8000 System contains the operation workstation software, which is installed on acquisition workstation ("AWS"), which contains monitor, keyboard and mouse, computer, electronics, and accessory storage. The resultant output signal can be transmitted to remote viewing sites, and/or it can be stored electronically for later viewing. The AWS is used for image acquisition, processing, and display. The AWS can also be used for database management and can send images to archive, review or filming.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
human anatomy
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Bench testing and electrical safety further substantiate equivalence to the predicate.
Electrical, mechanical safety and performance testing according to standard EN/IEC 60601-1(ed.2), EN/IEC 60601-1(ed.2);am1, and EN/IEC 60601-1(ed.2);am2 was performed, and EMC testing was conducted in accordance with standard IEC 60601-1-2: 2007(ed.3). All test results were satisfactory.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
Image /page/0/Picture/0 description: The image shows a logo with a stylized letter 'N'. The 'N' is bold and black, with a smaller, outlined 'M' nestled within the right side of the 'N'. The logo is simple and modern, with a focus on the letterforms.
MAR - 9 2012
Doc. NO. Rev. NO. 1.0 Issued date Page
15.of 51 2012.01.27
This 510k summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92
Saturn 8000
510k Submission
Initial Importer/Distributor Address:
New Medical Co., Ltd. No.32, 3F., Section 2, Zhongyang S. Rd., Beitou District, Taipei City 112, Taiwan, ROC +886-2-2892-2275 +886-2-2892-2172
Contact Person
Phone number:
Fax number:
Email: Phone: Fax:
Manufacturer
WesleyL@newmedical.com.tw +886-2-2892-2275 +886-2-2892-2172
Vieworks Co., Ltd #604 Suntechcity II, 307-2 Sangdaewon-dong, Jungwon-gu, Seongnam-city, Gyeonggi-do, 462-806, South Korea Tel: +82-70-7011-6161 Fax: +82-31-737-4954
Device Name and Classification Trade name/Product Name: Classification name: Common name: Product Code: Regulation Number
Saturn 8000 System Stationary X-ray System General purpose diagnostic X-ray System MQB 892.1650
Date Prepared
2011.01.27
Substantial Equivalence claimed to:
Samsung LTX240AA01-A
Copyright © 2012
New Medical Co., Ltd. Confidential
1
Image /page/1/Picture/0 description: The image shows a logo with the letters 'N' and 'M' intertwined. The 'N' is larger and bolder, with a solid black fill. The 'M' is smaller and positioned slightly below and to the right of the 'N'. The 'M' has a textured or patterned fill, giving it a different visual appearance compared to the 'N'. The logo has a simple, yet distinct design.
Device Description
The "Digital X-ray Capture Device (Saturn 8000 System)" (as Saturn 8000 System) is equipped with digital detector. X-ray generator interface, and image acquisition. The digital detector is a flat panel detector. The input X-ray photons are absorbed in scintillator layer that creates a visible light photon, and then the photon is absorbed in TFT-array to create an electrical charge which is representation of the X-ray inout. The charge is read-out by a matrix scan of the array that converts the charges into a modulated electrical signal. Interfacing with generator can be achieved by Automatic Exposure Detection ("AED") technology which allows detector to automatically detects X-ray exposure. The Saturn 8000 System contains the operation workstation software, which is installed on acquisition workstation ("AWS"), which contains monitor, keyboard and mouse, computer, electronics, and accessory storage. The resultant output signal can be transmitted to remote viewing sites, and/or it can be stored electronically for later viewing. The AWS is used for image acquisition, processing, and display. The AWS can also be used for database management and can send images to archive, review or filming.
Indications for Use
The Saturn 8000 system generates digital X-ray images that can be used for general X-ray system except fluoroscopic, angiographic, and mammographic applications. The Saturn 8000 system can interface to any X-ray generator and get digital X-ray image. The Saturn 8000 is intended to be used in same clinical application as traditional film-screen based general radiography system.
Substantial Equivalence
The Saturn 8000 System is substantially equivalent to the commercially available Samsung LTX240AA01-A cleared as 510k K090742. Bench testing and electrical safety further substantiate equivalence to the predicate. The Saturn 8000 System utilizes the Vieworks VIVIX-S panel and LTX240AA01-A is manufactured by Samsung Mobile Display Co., Ltd.
General Safety and Effectiveness Concerns
Electrical, mechanical safety and performance testing according to standard EN/IEC 60601-1(ed.2), EN/IEC 60601-1(ed.2);am1, and EN/IEC 60601-1(ed.2);am2 was performed, and EMC testing was conducted in accordance with standard IEC 60601-1-2: 2007(ed.3). All test results were satisfactory.
Copyright © 2012
New Medical Co., Ltd. Confidential
16/5,1
2
Image /page/2/Picture/0 description: The image shows a stylized logo with the letters 'N' and 'I' intertwined. The 'N' is larger and bolder, appearing in black with a textured, almost distressed look. The 'I' is smaller and positioned to the right of the 'N', also in black but with a similar textured effect. The overall design has a slightly edgy or urban feel due to the distressed texture.
Saturn 8000 510k Submission
| Doc. NO. | |
|---|---|
| Rev. NO. | 1.0 |
| Issued date | |
| 2012.01.27 | Page |
| 17 of 51 |
Conclusion
The results of all testing demonstrate that the Saturn 8000 does not raise any new significant issues of safety, effectiveness or performance of the device when compare to the existing predicate devices.
Copyright © 2012
New Medical Co., Ltd. Confidential
17/51
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing-like shapes, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle symbol. The logo is presented in black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
9 2012 MAR -
New Medical Co., Ltd. % Mr. Jun-Hsiung Lin New Medical Co., Ltd. 1441 Kem Way WALNUT CA 91789
Re: K120380
Trade/Device Name: Saturn 8000 System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: MQB Dated: January 27, 2012 Received: February 2, 2012
Dear Mr. Lin:
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, Dray, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmetic recry that as novice, subject to the general controls provisions of the Act. The r ou may, therefore, manol at the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such 11 your device is clussified (bee acor regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 I loase of action and I Dr. Direction that your device complies with other requirements of the Act that I Dri has intact a and regulations administered by other Federal agencies. You must of any I oderal statutes and regulaments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of
4
Page 2
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter requirences as over in in in in in the as described in your Section 510(k) premarket with anow you to begin malinential equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 11 you don't be office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket 9 150. Those note 1800 1000 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Image /page/5/Picture/0 description: The image shows a stylized, bold letter 'N'. The letter is primarily black, with some areas appearing slightly faded or textured, giving it a somewhat distressed look. The overall impression is of a simple, yet striking, graphic element.
Saturn 8000 510k Submission
| Doc. NO. | |
|---|---|
| Rev. NO. | 1,0 |
| Issued date | 2012.01.27 |
| Page | 13 of 51 |
510(K) Number (if known):
Device Name: Saturn 8000 System
Indications For Use:
The Digital X-ray Capture Device Saturn 8000 Systems is indicated for use in general radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures (excluding fluoroscopic, angiographic, and mammographic applications).
Prescription Use V (Part 21 CFR 801 Subpart D)
·AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mary Pastel
(Division Sign-Off)
Division of Radiological De Office of In Vitro Diagnostic Device Eva
Copyright © 2012
New Medical Co., Ltd. Confidential 510K
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