(135 days)
Not Found
No
The device description details a purely mechanical and manual x-ray collimator with no mention of automated adjustments, data analysis, or any computational elements that would suggest AI/ML.
No
The device is described as an X-ray collimator intended for use in "diagnostic radiographic/fluoroscopic applications," which indicates it is used for imaging and diagnosis, not for treating diseases or conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for use in diagnostic radiographic/fluoroscopic applications." This directly indicates its role in diagnosis.
No
The device description clearly details physical components such as shutters, knobs, a light beam, and a Lexan window, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "for use in diagnostic radiographic/fluoroscopic applications." This describes a device used in medical imaging to produce images of the inside of the body using X-rays.
- Device Description: The description details a device that physically shapes and limits the X-ray beam. This is a component of an X-ray imaging system, not a device used to examine specimens derived from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing information about a patient's health status based on in vitro testing.
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 a physical component of an X-ray machine used for imaging.
N/A
Intended Use / Indications for Use
R104/A, R108 and R108 F Manual X-Ray Collimators are intended for use in diagnostic radiographic/fluoroscopic applications.
Product codes
IZX
Device Description
These are square-field single- or, optionally, multi-layer x-ray collimators. They are lightweight and compact, suited for installation on mobile of fired x-ray equipment. In the standard single- layer version, the x-ray field is defined by two pairs of shutters and a conc at the xray beam window. In the version mounting RO 334, he x-ray field is defined by six pairs of shutters, two of which are leadlined. The six pairs of shutters move perpendicularly within the x-ray field. Four pairs of shutters are in bronze: two are located near the focus and two are leated near the entrance window. Two leaded shutters are located near the exit window of the x-ray beam from the collimator and serve to accurately define the x-ray field edges. Shutter movements are manual and controlled by two knobs on the collimator from panel. The square-field X-ray beam Limiting Device is designed for installation on rotating or fixed anode Xray tubes (mounting RO 334) (EN 60601-1-3 par 29.202.3); manual controls provide for the adjustment of the X-ray field dimension to the size of the image receptor or to that of the anatomical area of interest. Adjustment to the area under investigation is possible by using the knobs on the front panel. Direct visualisation of the x-ray field is provided by a light beam which corresponds to the x-ray bean, within a tolerance of two percent of the selected FFD (SID) value. The light-field centre is provided by the intersection of two perpendicular lines silk-screened into the Lexan window and projected on the light field by the light beam. To activate the light field, press the area marked with the light symbol on the front of the device. The light will switch on for 30 seconds and an electronic timer will switch the lamp OFF automatically.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
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)
The results of bench, safety test, and laboratory testing indicates that the new devices are as safe and effective as the predicate device. The predicate employs a square field, same as our new device. The new devices conform to US Performance Standards and are CSA Listed to US Standards for safety for medical devices.
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
§ 892.1610 Diagnostic x-ray beam-limiting device.
(a)
Identification. A diagnostic x-ray beam-limiting device is a device such as a collimator, a cone, or an aperture intended to restrict the dimensions of a diagnostic x-ray field by limiting the size of the primary x-ray beam.(b)
Classification. Class II (special controls). The 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
AUG 1 0 2011
RALCO srl Via dei Tigli 13/G 20046 Biassono (mi) Italy Tel. +39.039.249.7925 Fax: +39.039.249.7799 email: ralco@ralco.it Date prepared: March 18, 2011 Contact person: Vincenzo Velardi, President and CEO
Identification of the Device: 1.
Proprietary-Trade Name: R104/A, R108 and R108 F Manual X-Ray Collimators Classification Name: collimator, automatic, radiographic, Product Code IZX Common/Usual Name: Manual X-Ray Collimator.
Equivalent legally marketed devices: K030487 Ralco R72 Manual Collimator. 2.
Indications for Use (intended use): Intended for use in diagnostic/fluoroscopic applications. 3.
- Description of the Device: These are square-field single- or, optionally, multi-layer x-ray 4. collimators. They are lightweight and compact, suited for installation on mobile of fired x-ray equipment. In the standard single- layer version, the x-ray field is defined by two pairs of shutters and a conc at the xray beam window. In the version mounting RO 334, he x-ray field is defined by six pairs of shutters, two of which are leadlined. The six pairs of shutters move perpendicularly within the x-ray field. Four pairs of shutters are in bronze: two are located near the focus and two are leated near the entrance window. Two leaded shutters are located near the exit window of the x-ray beam from the collimator and serve to accurately define the x-ray field edges. Shutter movements are manual and controlled by two knobs on the collimator from panel. The square-field X-ray beam Limiting Device is designed for installation on rotating or fixed anode Xray tubes (mounting RO 334) (EN 60601-1-3 par 29.202.3); manual controls provide for the adjustment of the X-ray field dimension to the size of the image receptor or to that of the anatomical area of interest. Adjustment to the area under investigation is possible by using the knobs on the front panel. Direct visualisation of the x-ray field is provided by a light beam which corresponds to the x-ray bean, within a tolerance of two percent of the selected FFD (SID) value. The light-field centre is provided by the intersection of two perpendicular lines silk-screened into the Lexan window and projected on the light field by the light beam. To activate the light field, press the area marked with the light symbol on the front of the device. The light will switch on for 30 seconds and an electronic timer will switch the lamp OFF automatically.
- . 5. Safety and Effectiveness, comparison to predicate device. The results of bench, safety test, and laboratory testing indicates that the new devices are as safe and effective as the predicate device. The predicate employs a square field, same as our new device. The new devices conform to US Performance Standards and are CSA Listed to US Standards for safety for medical devices.
- Conclusion: After analyzing both bench and safety testing data, it is the conclusion of Ralco that the 6. R104/A, R108 and R108 F Manual X-Ray Collimators are as safe and effective as the predicate device, have few technological differences, and has identical indications for use, thus rendering them substantially equivalent to the predicate device.
1
Image /page/1/Figure/0 description: The image shows two comparison photographs of two different devices. The device on the left is labeled "Predicate", and the device on the right is labeled "R104/A". Both devices appear to be housed in square or rectangular enclosures with cylindrical features on the sides and circular features on top. The image is presented in black and white.
R108 R108
F
Image /page/1/Figure/2 description: The image shows two different electronic devices. Both devices are box-shaped and appear to be made of metal. The device on the left has a circular opening on top and several knobs on the front. The device on the right has a similar circular opening on top, as well as a display screen and knobs on the front.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
RALCO S.R.L. % Mr. Daniel Kamm. P.E. Regulatory Engineer Kamm & Associates 8870 Ravello Ct NAPLES FL 34114
AUG 10 2011
Re: K110856
Trade/Device Name: R104/A. R108 and R108 F Manual X-Ray Collimators Regulation Number: 21 CFR 892.1610 Regulation Name: Diagnostic x-ray beam limiting device Regulatory Class: II Product Code: IZX Dated: August 7. 2011 Received: August 8, 2011
Dear Mr. Kamm:
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. Iisting 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,
Mary Patel
Mary S. Pastel. Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K1117 88
Device Name: R104/A, R108 and R108 F Manual X-Ray Collimators
Indications For Use:
R104/A, R108 and R108 F Manual X-Ray Collimators are intended for use in diagnostic radiographic/fluoroscopic applications.
Prescription Use _ X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mary Scott
(Dission Sig Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510K K110856
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