(71 days)
Not Found
No
The description focuses on standard x-ray imaging components and functionalities, with no mention of AI or ML.
No
The device is an imaging system (fluoroscopic x-ray and radiographic imaging) and is intended for diagnostic purposes, not for treating a condition or disease.
Yes
The "Intended Use / Indications for Use" states that "UROlogic is intended to provide fluoroscopic and radiographic imaging of the patient during diagnostic, surgical and interventional procedures." The "Device Description" also refers to it as a "universal fluoroscopic x-ray diagnostic system."
No
The device description explicitly lists multiple hardware components including a patient support table, x-ray generator, image intensifier, TV system, CCD camera, x-ray tube, image monitor, and control panels. This indicates it is a hardware-based system, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
- Device Description: The provided description clearly states that UROlogic is an x-ray diagnostic system used for fluoroscopic and radiographic imaging of the patient. This involves generating images of the patient's internal structures within the body using x-rays.
- Intended Use: The intended use is for imaging during diagnostic, surgical, and interventional procedures, which are performed directly on the patient.
The device is an imaging system used for in-vivo (within the living body) diagnosis and procedures, not for testing samples in a laboratory setting.
N/A
Intended Use / Indications for Use
UROlogic is intended to provide fluoroscopic and radiographic imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include but are not limited to urologic and endoscopic applications The system may be used for other imaging applications at physician's discretion.
Product codes
90 JAA, OWB, JAA
Device Description
UROlogic is a universal fluoroscopic x-ray diagnostic system intended for use in providing x-ray imaging of patient with an undertable image intensifier. The system consists of a floor mounted tilting patient support table, x-ray generator, xsystem or a sembly, image intensifer and the tv system. The system is operated via tableside control panel, foot/handswitches and x-ray control panel. The system comes with a tripple mode image intensifier, a CCD camera with one frame memory, x-ray tube with housing and an image monitor.
The tabletop can be moved motorized in longitudinal and lateral directions. The table can be tilted -15 to +87 degrees. Cranial movement of connected x-ray tube and image intensifer assembly gives the operator the advantage of scanning without moving patient. System has a stationary grid and casette holder for wallow mo films. Patient positioning and other accessories are also provided.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray, fluoroscopic, radiographic
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)
Reference Device(s)
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
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
510(k) Application
UROlogic
ÍJÚL 1 0 2001
Image /page/0/Picture/3 description: The image shows a logo with a geometric design on the left and the letters "PCK" on the right. The geometric design resembles a wheel or a stylized flower with six petals or sections. A horizontal line extends from the right side of the geometric design, underlining the letters "PCK". The letters are in a bold, sans-serif font and appear to be a part of the company's name or brand.
×011311
ELECTRONIC INDUSTRY AND TRADE CO, LTD
TURAN GUNES BUL KONRAD AD CAD 59/1 SANCAK, CANKAYA, 06550 ANKARA, TURKEY TEL:+90 312 491 6010 FAX:+90 312 491 601 1
30 APR 2001
510(k) Summary
This summary of 510(k) safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
- Applicant
PCK ELECTRONIC INDUSTRY AND TRADE CO, LTD TURAN GUNES BUL KONRAD AD CAD 59/1 SANCAK CANKAYA, 06550 ANKARA TURKEY
TEL:+90 312 491 6010 FAX:+90 312 491 6011
CONTACT PERSON: CENGİZ KABAKCI ASSISTANT GENERAL MANAGER
- Device Identification
| Proprieatary Device Name: | UROlogic Urological Table |
|---|---|
| Common/Generic Device Name: | Fluorocsopic Imaging System, Urological Table |
| Classification Name: | SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED |
| Product Code: | 90 JAA |
| Regulatory Class: | Class II |
| Regulation Number: | 21 CFR 892.1650 |
1
:
3. Substantial Equivalence
The UROlogic Urological Table is substantially equivalent to the following currently marketed devices:
4. Description of Device
UROlogic is a universal fluoroscopic x-ray diagnostic system intended for use in providing x-ray imaging of patient with an undertable image intensifier. The system consists of a floor mounted tilting patient support table, x-ray generator, xsystem or a sembly, image intensifer and the tv system. The system is operated via tableside control panel, foot/handswitches and x-ray control panel. The system comes with a tripple mode image intensifier, a CCD camera with one frame memory, x-ray tube with housing and an image monitor.
The tabletop can be moved motorized in longitudinal and lateral directions. The table can be tilted -15 to +87 degrees. Cranial movement of connected x-ray tube and image intensifer assembly gives the operator the advantage of scanning without moving patient. System has a stationary grid and casette holder for wallow mo films. Patient positioning and other accessories are also provided.
5. Intended Use
UROlogic is intended to provide fluoroscopic and radiographic imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include but are not limited to urologic and endoscopic applications The system may be used for other imaging applications at physician's discretion.
6. Technological Characteristics
URO!ogic Urological Table employs the same technological characteristicsas the predicate devices. This device is intended for the same applications as the currently marketed predicate devices. All systems are image intensified x-ray imaging systems with an overtable x-ray tube assembly. Like the predicate devices, UROlogic Urological Table consists of basic the basic patient suport table, and standard system components: x-ray generator, x-ray tube, Image Intensifier, TV system and monitor(s).
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are simple and abstract, with a curved line representing the forehead, nose, and chin. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Mr. Cengiz Kabakci Assistant General Manager PCK Electronic Industry and Trade Co, Ltd. Turan Gunes Bul Konrad AD CAD 59/1 Sancak CANKAYA 06550 ANKARA TURKEY
1 6 2012 N VA
Re: K011311
Trade/Device Name: IURO) Logic (Urology x-ray table) Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB and JAA Dated: April 30, 2001 Received: April 30, 2001
Dear Mr. Kabakci:
This letter corrects our substantially equivalent letter of July 10, 2001.
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
3
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
4
STATEMENT OF INDICATIONS FOR USE
Applicant:
PCK ELECTRONIC INDUSTRY AND TRADE CO, LTD
TURAN GUNES BUL KONRAD ADENAUER CAD 59/1 SANCAK, CANKAYA O6550, ANKARA TURKIYE
510(k) NUMBER: K011311
UROlogic Urological Table DEVICE NAME:
INDICATIONS FOR USE:
UROlogic is intended to provide fluoroscopic and radiographic imaging of the patient during diagnostic, surgical and interventional procedures
Prescription Use
David A. Seigman
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological I 510(k) Number