(65 days)
No
The summary describes a standard radiographic X-ray system and does not mention any AI or ML capabilities. The sections specifically looking for mentions of AI/ML, training data, and performance metrics related to AI/ML are all marked as "Not Found".
No.
The device is described as a radiographic system used for generating diagnostic images, not for providing therapy.
Yes
The device is described as generating "diagnostic images" for various body parts, which indicates its use in diagnosing medical conditions.
No
The device description clearly outlines multiple hardware components (ceiling suspension, bucky wall stand, bucky table, X-ray generator, X-ray tube, portable wireless and fixed detector) that constitute the Ysio system. This is not a software-only device.
Based on the provided information, the Ysio system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. This includes things like blood, urine, tissue samples, etc., to provide information about a physiological state, health, or disease.
- The Ysio system is a radiographic system. It uses X-rays to create images of the internal structures of the body. It does not analyze biological specimens.
- The intended use clearly describes imaging procedures. The system is used for radiographic and tomographic exposures of the whole body, for various applications like diagnosis, interventions, and emergency situations.
Therefore, the Ysio system falls under the category of medical imaging devices, not IVD devices.
N/A
Intended Use / Indications for Use
The Ysio (New RAD -FAMILY) systems are radiographic systems used in hospitals, clinics, and medical practices. Ysio enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critical ill) applications. Exposures may be taken with the patient sitting, standing, or in the prone position. The Ysio system is not meant for mammography.
The Ysio uses an integrated or portable digital detector for generating diagnostic images by converting x-rays into electronic signals. Ysio is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes.
Product codes (comma separated list FDA assigned to the subject device)
90MQB, KPR
Device Description
The Ysio Radiography X-ray system is designed as a set of components such as ceiling suspension, bucky wall stand, bucky table, X-ray generator, X-ray tube, a portable wireless and a fixed detector, that may be combined into different configurations to provide specialized customer requirements.
The Ysio Radiography X-ray system is based on the currently available medical devices as listed in section 5.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
whole body including: skull, chest, abdomen, and extremities
Indicated Patient Age Range
pediatric, adult and bariatric patients
Intended User / Care Setting
hospitals, clinics, and medical practices.
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)
Not Found
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.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
K0817222
SECTION 5
AUG 2 5 2008
510(k) Summary FOR SIEMENS Ysio
Submitted by: Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway Malvern, PA 19355
June 12, 2008
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR $807.92.
1. Contact Person:
P
Mr. Gary Johnson Technical Specialist, Regulatory Affairs Submissions Siemens Medical Solutions USA. Inc 51 Valley Stream Parkway E-50 Malvern, PA 19355-1406 Phone:(601) 448-1778 Fax: (610) 448-1787
2. Device Name and Classification
| Trade Name: | Ysio |
|---|---|
| Classification Name: | Solid State X-ray Imager (SSXI) |
| Classification: | Panel: Radiology |
| CFR Section: | 21 CFR §892.1680 |
| Device Class: | Class II |
| Device Code: | 90MQB |
3. Intended Use:
The Ysio (New RAD -FAMILY) systems are radiographic systems used in hospitals, clinics, and medical practices. Ysio enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critical ill) applications. Exposures may be taken with the patient sitting, standing, or in the prone position. The Ysio system is not meant for mammography.
The Ysio uses an integrated or portable digital detector for generating diagnostic images by converting x-rays into electronic signals. Ysio is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes.
1
4. Device Description:
The Ysio Radiography X-ray system is designed as a set of components such as ceiling suspension, bucky wall stand, bucky table, X-ray generator, X-ray tube, a portable wireless and a fixed detector, that may be combined into different configurations to provide specialized customer requirements.
The Ysio Radiography X-ray system is based on the currently available medical devices as listed in section 5.
5. Substantial Equivalence:
The Ysio Radiography x-ray system is designed with a portable wireless and a fixed detector. The new ceiling mounted configuration allows acquisition of radiographic exposures of various anatomical regions of the body. It is substantially equivalent to the following SIEMENS Medical Systems devices:
| 510(k) Number | Date of Clearance | Device Name |
|---|---|---|
| K983732 | April 21, 1999 | Thorax FD and Multix FD (AXIOM Aristos TX / MX) |
| K061054 | May 09, 2006 | AXIOM Aristos FX Plus (Wireless Remote) |
| K062623 | August 22, 2007 | AXIOM Luminos dRF |
Many of the components used on the Ysio i.e. x-ray generator, x-ray tube, user interface, displays are used from already cleared medical devices. Some components i.e. collimator, flat detector, digital imaging system and tables include same or improved functionality.
The Wireless Interface of the mobile detector is substantially equivalent to the wireless interface of the Krystal-X WiFi wireless digital X-ray sensor from Video Dental Concepts, Inc.
| 510(k) Number | Date of Clearance Device Name | AR-110-24-0 - 10-2019 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 |
|---|---|---|
| K070505 | April 5, 2007 | Krystal-X WiFi |
A detailed Substantial Equivalence Comparison is provided in Section 12.
. B
2
Summary of Technological Characteristics of the Principal Device as compared with 6. the Predicate Device:
The Ysio Radiography X-ray system is designed as a set of components (ceiling suspension, bucky wall stand, bucky table, X-ray generator, X-ray tube, a portable wireless and a fixed detector etc.) that may bc combined into different configurations to provide specialized customer requirements. Many of the components used with Ysio are either commercially available with current Siemens systems or include minor modifications to existing components.
7. General Safety and Effectiveness Concerns:
Instructions for use are included within the device labeling, and the information provided will enable the user to operate the device in a safe and effective manner. Several safety features including visual and audible warnings are incorporated into the system design. In addition the Ysio Radiography X-ray system is continually monitored, and if an error occurs, the system functions will be blocked and an error message will be displayed. Furthermore the operators are health care professionals familiar with and responsible for the X-ray examinations to be performed. To minimize electrical, mechanical and radiation hazards, Siemens adheres to recognized and established industry practice, and all equipment is subject to final performance testing.
3
Image /page/3/Picture/0 description: The image shows the logo of the Department of Health & Human Services. The logo consists of a symbol on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. The symbol is a stylized image of an eagle or bird, and the text is in a bold, sans-serif font.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Gary Johnson Regulatory Technical Specialist Siemens Medical Solutions USA. Inc. 51 Valley Stream Parkway E-50 MALVERN PA 19355-1406
AUG 21 2013
Re: K081722 Trade/Device Name: YSIO Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray System Regulatory Class: II Product Code: KPR Dated: June 17, 2008 Received: June 28, 2008
Dear Mr. Johnson:
This letter corrects our substantially equivalent letter of August 25, 2008.
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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major 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 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 Parts 801 and 809); medical device reporting (reporting of
4
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 will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial 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 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 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
SECTION 4
INDICATIONS FOR USE
510(k) Number (if known): Device Name: YSIO
Indications for Use:
The Ysio (New RAD -FAMILY) systems are radiographic systems used in hospitals, clinics, and medical practices. Ysio enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critical ill) applications. Exposures may be taken with the patient sitting, standing, or in the prone position. The Ysio system is not meant for mammography.
The Ysio uses an integrated or portable digital detector for generating diagnostic images by converting x-rays into electronic signals. Ysio is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
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(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number ..
510(k) Ysio
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Siemens Medical Systems, Inc.