(152 days)
Not Found
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no other information suggesting the use of AI/ML.
No
The provided information indicates that the ddRElement is a Digital Radiography system used for examinations, which means it is a diagnostic imaging device rather than a device intended for treating a disease or condition.
No
Explanation: The device is described as a "Digital Radiography system developed to be used for Medical General Radiography examinations," which focuses on image acquisition for examination rather than diagnosis. It does not mention any diagnostic capabilities such as disease detection, measurement, or analysis for aiding in a diagnosis.
No
The device is described as a "Digital Radiography system," which inherently includes hardware components for image acquisition (like an X-ray detector). The summary does not indicate it is solely software processing data from an external source.
Based on the provided information, the ddRElement is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "Digital Radiography system developed to be used for Medical General Radiography examinations on standing, seated and supine patients." This describes an imaging device used to capture images of the inside of the body, which is a form of in vivo (within the living body) diagnostic imaging.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. The ddRElement does not perform tests on such samples.
- Device Description: The description confirms it's a "Digital Radiography system," which aligns with an imaging device, not an IVD.
Therefore, the ddRElement is a medical imaging device used for diagnostic purposes, but it operates in vivo, not in vitro.
N/A
Intended Use / Indications for Use
The ddRElement is a Digital Radiography.system developed to be used for Medical General Radiography.examinations on standing; seated and supine pattents
Product codes
KPR and MOB
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Digital Radiography
Anatomical Site
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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 the logo for the Department of Health & Human Services. The logo consists of a stylized human figure in blue, along with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in blue font. The logo is simple and professional, and it is easily recognizable.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Swissray Medical AG % Mr. John Monahan Official Correspondent Swissray International. Inc. One Tower Center EAST BRUNSWICK NJ 08816
AUG 2 0 2013
Re: K110828
Trade/Device Name: ddR Element Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR and MOB Dated: August 2. 2011 Received: August 4, 2011
Dear Mr. Monahan:
This letter corrects our substantially equivalent letter of August 23, 2011.
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
1
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
2
ndications for Use Form (Text Version)
ndications for Use
510(k) Number (if known) K110828
510(KN)Number (if khown) "K110828" अभी र 2017 - 11:28 PM IST 2017 - 11:28 PM IST 2019 - 11:28 PM IST - 11:28 PM IST - 11:28 PM - 11:28 PM - 11:28 PM - 11:28 PM - 11:28 PM - 1
indications for USe . The ddRElement is a Digital Radiography.system developed to be used for Medical
General Radiography.examinations on standing; seated and supine pattents
Prescription Use Required (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOTAY RELOWATHIS LINE CONTAINUE ONLANOTHER PAGE OF NEEDED
consumence of continto fire a bogice avaluation (obja
Page Carola C
Mary S. Pão V.
(Division Sign-Off) Division of Rediological Device Office of In Vitro Disgnostic Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K110828