(42 days)
No
The document does not mention AI, ML, deep learning, or any related terms, nor does it describe any features or functionalities typically associated with AI/ML in medical imaging (e.g., automated detection, segmentation, or analysis). The focus is on the integration of existing, cleared components.
No
The device is described as a "Stationary Radiographic System" intended for "taking diagnostic radiographic exposures," which means it is used for imaging and diagnosis, not for treating diseases or medical conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is used for "taking diagnostic radiographic exposures".
No
The device description explicitly states it is a "new combination of an already cleared solid state digital x-ray acquisition panel with software and diagnostic x-ray components required to make a complete system." It also lists specific hardware components like the x-ray generator, tubes, and collimator.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for taking "diagnostic radiographic exposures" of various body parts. This involves imaging the internal structures of the body using X-rays.
- Device Description: The description details components like an X-ray generator, X-ray tubes, and a collimator, all of which are characteristic of an X-ray imaging system. It also mentions the use of a digital X-ray acquisition panel or film cassettes.
- Input Imaging Modality: The input modality is "Diagnostic radiographic exposures," which is an in-vivo imaging technique.
- Anatomical Site: The device is used to image various anatomical sites within the body.
In Vitro Diagnostics (IVDs) are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, outside of the body (in vitro) to provide information for diagnosis, monitoring, or screening.
This device operates by generating X-rays that pass through the patient's body to create an image, which is an in-vivo diagnostic method, not an in-vitro method.
N/A
Intended Use / Indications for Use
The Jumong Series Stationary Radiographic System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest. abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
Product codes
KPR, MQB
Device Description
This device represents a new combination of an already cleared solid state digital x-ray acquisition panel with software and diagnostic x-ray compnents required to make a complete system. Film cassettes may be employed in place of the digital panel. The purchaser can select from one of four configurations. The x-ray generator is a CPI CMP 200DR. The x-ray tubes are supplied by Varian (RAD-14), and the collimator is the Ralco R225 ACS DHHS. The system complies with the CDRH Radiological Health performance standard in the Code of Federal Regulations, as well as the voluntary IEC standards IEC 60601-1 and IEC 60601-1-2. All major components are either UL or CSA listed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
skull, spinal column, chest. abdomen, extremities, and other body parts.
Indicated Patient Age Range
adult and pediatric subjects
Intended User / Care Setting
qualified/trained doctor or technician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing: integration testing. The results of a review of bench, safety test, and software validation documentation indicates that the new device is as safe and effective as the predicate device. The device conforms to US Performance Standards.
Clinical testing: Clinical images were provided; these images were not necessary to establish substantial equivalence based on the modifications to the device (e.g., use of previously cleared detectors) but they provide further evidence in addition to the laboratory performance data to show that the complete system works as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K103591, K091436, K111682, K122865, K122866, K120020, K090238
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle with three lines representing its wings and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 13, 2016
SG HealthCare Co., Ltd. % Mr. Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Court NAPLES FL 34114
Re: K150816
Trade/Device Name: Jumong Series Stationary Radiographic System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR, MQB Dated: March 20, 2015 Received: March 27, 2015
Dear Mr. Kamm:
This letter corrects our substantially equivalent letter of May 8, 2015
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
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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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
Michael D'Hara
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) K150816
Device Name
Jumong Series Stationary Radiographic Systems
Indications for Use (Describe)
The Jumong Series Stationary Radiographic System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest. abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
| 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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510(K) Summary, 510(k) K150816 Submitter: SG Healthcare Co., Ltd. 753 ITECO, 150 Jojeong-Daero, Hanam-Si, Gyeonggi-Do, 465-736 Korea Tel : +82-70-7011-6161 FAX : +82-31-737-4954 Contact: YOSEP PARK, sales@sghealthcare.com Date Prepared: April 11, 2015
1. Identification of the Device:
Proprietary-Trade Name: Jumong Series Stationary Radiographic System Classification Name: Stationary X-Ray System, Product codes KPR and MQB Common/Usual Name: Diagnositc X-Ray System Device Class: II per regulation 21CFR 892.1680
2. Equivalent legally marketed device: K133782, Sedecal Nova FA DR System, Sedecal SA.
-
- Indications for Use The Jumong Series is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest. abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
-
- Description of the Device: This device represents a new combination of an already cleared solid state digital x-ray acquisition panel with software and diagnostic x-ray compnents required to make a complete system. Film cassettes may be employed in place of the digital panel. The purchaser can select from one of four configurations. Please see the photos below. The x-ray generator is a CPI CMP 200DR. The x-ray tubes are supplied by Varian (RAD-14), and the collimator is the Ralco R225 ACS DHHS. The system complies with the CDRH Radiological Health performance standard in the Code of Federal Regulations, as well as the voluntary IEC standards IEC 60601-1 and IEC 60601-1-2. All major components are either UL or CSA listed.
- Safety and Effectiveness, comparison to predicate device. This combination device has the same 5. indications for use and very similar technological characteristics as the predicate device, and employs already 510(k) cleared digital panels and software.
6. Substantial Equivalence Chart: Please see the next page.
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| Characteristic | Sedecal Nova FA K133782 | SG Healthcare, Co. Ltd., Jumong Series
Stationary Radiographic System |
|---------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | Sedlecal "NOVA FA DR System" is
intended for use by a qualified, trained
doctor or technician on both adult and
pediatric subjects for taking diagnostic
radiographic exposures of the skull,
spinal column, chest. abdomen,
extremities, and other body parts.
Applications can be performed with
the patient sitting, standing, or lying in
the prone or supine position. Not for
mammography. | Jumong Series is intended for use by a
qualified, trained doctor or technician on
both adult and pediatric subjects for taking
diagnostic radiographic exposures of the
skull, spinal column, chest. abdomen,
extremities, and other body parts.
Applications can be performed with the
patient sitting, standing, or lying in the
prone or supine position. Not for
mammography. |
| Configuration
of Digital
Panels | Battery or AC operated wireless IEEE
802.11n or Wired Ethernet | SAME |
| Digital Panel
Models and
their clearance
numbers | CXDI Canon Detector 401C/401C
Compact (K103591)
CXDI Canon Detector 55C (K091436)
CXDI Canon Detector 501C
(K111682) | Vieworks
K122865 Vivix-S Wireless
K122866 Vivix-S With Vxvue
K120020 Vivix-S |
| Image
acquisition
panel
specifications | 3,320 x 3,408 125 µm (401C) or
2,208 x 2,688 pixels 160 µm (55C)
2,800 x 3,408 Pixels 125 µm (501C) | FXRD-1717SA, FXRD-1717SB)
3,072 x 3,072, 140µm or
FXRD-1417SA, FXRD-1417SB)
2560 x 3072, 140μm
Wireless: FXRD-1417WA, FXRD-
1417WB, 2560 x 3072, 140μm |
| DICOM | DICOM 3 | DICOM 3 |
| WiFi Wireless
IEEE802.11n
(All others are
Ethernet
Tethered.) | Not applicable, but compatible with
all Canon panels, including wireless. | K122865 Vivix-S Wireless |
| Image
acquisition
software | CANON cleared in K111682 | Vieworks as cleared in K122866 Vivix-S
With Vxvue |
| Power Source | AC Line. various voltages available | SAME |
| Characteristic | Sedecal Nova FA K133782 | SG Healthcare, Co. Ltd., Jumong Series Stationary Radiographic System |
| Photos | Image: Sedecal Nova FA K133782 | Image: Jumong M
Image: Jumong General
Image: Junong E |
| Alternate
configuration | Sedecal X-Plus LP Plus, K090238
Sedecal | Image: Jumong U |
| Generator | Sedecal SHF | CPI CMP 200DR |
| Collimator | Ralco R225 | Ralco R225 |
| Characteristic | Sedecal Nova FA K133782 | SG Healthcare, Co. Ltd., Jumong Series
Stationary Radiographic System |
| Performance
Standard | FDA 21CFR1020.30-31 | SAME |
| Electrical safety | Electrical Safety per IEC-60601. UL listed | SAME |
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6
-
- Summary of non-clinical testing: We performed integration testing. The results of a review of bench, safety test, and software validation documentation indicates that the new device is as safe and effective as the predicate device. The device conforms to US Performance Standards. The device conforms to this list of voluntary standards:
| Standards
No. | Standards
Organization | Standards Title | Version | Date |
|-------------------------|---------------------------|--------------------------------------------------------------------------------------------------------------------------------|-----------------------|---------------------|
| 60601-1 | IEC | Safety of Electrical Medical Equipment | 2005 + A1
(2012) | 2005 + A1
(2012) |
| 60601-1-2 | IEC | Electromagnetic Compatibility | 2007 | 2007 |
| 60601-1-3: | IEC | Collateral Standard Radiation protection in
diagnostic X ray equipment | 2008 | 2008 |
| 60601-1-6 | IEC | Collateral standard: Usability | 2010 3ed.
+A1:2013 | 2010-2013 |
| 60601-2-28 | IEC | Particular requirements for the basic safety and
essential performance of X-ray tube assemblies
for medical diagnosis | 2010, 2ed | 2010 |
| 60601-2-54 | IEC | Particular requirements for the basic safety and
essential performance of X-ray equipment for
radiography and radioscopy | 2009 1ed | 2009 |
| 62366 | IEC | Application of usability engineering to medical
devices | 2007-1ed | 2007 |
| PS 3.1 - 3.18
(2009) | NEMA | Digital Imaging and Communications in
Medicine (DICOM) Set (This applies to the
Digital Panel) | 3 | 2009 |
-
- Summary of clinical testing: Clinical images were provided; these images were not necessary to establish substantial equivalence based on the modifications to the device (e.g., use of previously cleared detectors) but they provide further evidence in addition to the laboratory performance data to show that the complete system works as intended.
-
- Conclusion: After analyzing software integration validation, safety testing data, and clinical images, it is the conclusion of SG Healthcare that the "Jumong Series" is as safe and effective as the predicate device, has few technological differences, and has identical indications for use, thus rendering it substantially equivalent to the predicate device.