(53 days)
Not Found
No
The description details a microprocessor controlling stepper motors for mechanical adjustments, which is standard automation, not AI/ML. There are no mentions of AI, ML, or related concepts, nor any descriptions of training or test data sets typically associated with AI/ML development.
No.
The 'Intended Use' section states it is for "diagnostic radiographic/fluoroscopic applications," indicating it is used for imaging and diagnosis, not for treating diseases or conditions.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device "is intended for use in diagnostic radiographic/fluoroscopic applications." This indicates its role in the diagnostic process.
No
The device description explicitly mentions hardware components such as stepper motors, shutters, an additional filter, and a microprocessor circuit, which are integral to its function as an automatic x-ray collimator.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "diagnostic radiographic/fluoroscopic applications." This refers to imaging procedures performed on a patient's body, not tests performed on samples taken from the body (like blood, urine, or tissue).
- Device Description: The description details an "x-ray collimator," which is a component of an X-ray machine used to shape and control the X-ray beam. This is a piece of equipment used during an imaging procedure, not for analyzing biological samples.
- Input Imaging Modality: The input modality is "X-RAY," which is an imaging technique, not a method for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
In summary, this device is an accessory for an X-ray imaging system, used for diagnostic imaging of the human body, which is distinct from in vitro diagnostics.
N/A
Intended Use / Indications for Use
Model R225 ACS Automatic X-RAY Collimator is intended for use in diagnostic radiographic/fluoroscopic applications.
Product codes (comma separated list FDA assigned to the subject device)
IZW
Device Description
This x-ray collimator Multilayer, square-field, automatic collimation system. Stepper motors control the movements of shutters and the additional filter. There is a mounting plane at 80 mm (3.15") from the focus. A microprocessor circuit controls the stepper motors and provides the stepless adjustment of the square field dimensions at variable FFD (SID). The field dimensions may be decreased and increased to the set value by two knobs placed on the collimator front panel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
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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 device is as safe and effective as the predicate device.
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.
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
§ 892.1610 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.
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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: May 18, 2009 Contact person: Vincenzo Velardi, President and CEO
1. Identification of the Device:
Proprietary-Trade Name: Model R225 ACS Automatic X-RAY Collimator Classification Name: collimator, automatic, radiographic, Product Code IZW Common/Usual Name: Automatic X-Ray Collimator.
- Equivalent legally marketed devices: K072780, Ralco Model R302DACS Automatic Collimator. 2.
- Indications for Use (intended use): Intended for use in diagnostic/fluoroscopic applications. 3.
- Description of the Device: This x-ray collimator Multilayer, square-field, automatic collimation 4. system. Stepper motors control the movements of shutters and the additional filter. There is a mounting plane at 80 mm (3.15") from the focus. A microprocessor circuit controls the stepper motors and provides the stepless adjustment of the square field dimensions at variable FFD (SID). The field dimensions may be decreased and increased to the set value by two knobs placed on the collimator front panel.
- Safety and Effectiveness, comparison to predicate device. The results of bench, safety test, and 5. laboratory testing indicates that the new device is as safe and effective as the predicate device. The predicate employs a round field, same as our new device. The new device conforms to US Performance Standards and is 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. Model R225 ACS 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.
Image /page/0/Figure/10 description: The image shows two different devices, labeled "Predicate" and "R225 ACS". Both devices are cube-shaped with control panels on the front. The "Predicate" device has a keypad and knobs, while the "R225 ACS" device has a display screen, buttons, and knobs.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUI 1 4 2009
RALCO, srl % Mr. Daniel Kamm Principal Consultant Kamm & Associates 333 Milford Rd. DEERFIELD IL 60015
Re: K091517
Trade/Device Name: Model R225 ACS Automatic Collimator Regulation Number: 21 CFR 892.1610 Regulation Name: Diagnostic x-ray beam-limiting device Regulatory Class: II Product Code: IZW Dated: May 20, 2009 Received: June 02, 2009
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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
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 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
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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 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 hitp://www.fda.gov/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Janine M. Morris
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K09 / S17
Model R225 ACS Automatic Collimator Device Name:
Indications For Use:
Model R225 ACS Automatic X-RAY Collimator is intended for use in diagnostic radiographic/fluoroscopic applications.
Prescription Use × (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 Device Evaluation (ODE)
Hubert Reever
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
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