(53 days)
Not Found
No
The device description focuses on mechanical components (shutters, knobs, disc) for controlling the X-ray field size. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies compare the device to a predicate based on safety and effectiveness, not algorithmic performance.
No
The device is a collimator, which is a component of an X-ray system used to limit the X-ray field size during diagnostic imaging. It is not used 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 or fluoroscopic applications."
No
The device description explicitly details physical components like an external cover, lead shutters, knobs, and a lead disc, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "for use in diagnostic radiographic or fluoroscopic applications". This describes a device used in vivo (within a living organism) for imaging, not in vitro (outside the body) for testing biological samples.
- Device Description: The description details a physical component of an X-ray system (a collimator) that shapes the X-ray beam. This is consistent with an imaging device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any processes typically associated with in vitro diagnostics.
Therefore, the Model R 72B Manual X-RAY Collimator is a medical device used in diagnostic imaging, not an IVD.
N/A
Intended Use / Indications for Use
Model R 72B Manual X-RAY Collimator is intended for use in diagnostic radiographic or fluoroscopic applications.
Product codes
KPW
Device Description
This is a compact collimator with an external cover in ABS plastic. It is a single-layer, square field radiological collimator. Its light weight and compact size allow cass. positioning and make it ideal for mobile and portable units. The X-ray field size is limited by two pairs of lead shutters controlled by two knobs located on the sides of the collimator and by o yead disc near the x-ray focus to reduce scattered radiation. An indexed scale provides information on the field set with the knobs.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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 device is as safe and effective as the predicate device.
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
510(K) Summary, K093596 Lumos, Inc. 45945 Trefoil Lane, Suite 112 Sterling, VA 20166 Office: (703) 796-1890 Fax: (703) 796-1893 Date prepared: November 18, 2009
Contact person: James Whittaker, President and CEO
JAN 1 2 2010
Identification of the Device: 1.
Proprietary-Trade Name: Model R 72B Manual X-RAY Collimator Classification Name: collimator, manual, radiographic, Product Code KPW Common/Usual Name: Manual X-Ray Collimator.
- Equivalent legally marketed devices: This device is IDENTICAL to the Ralco Model R72 2. (K030487). This submission sets a baseline for Lumos Inc. to manufacture and control the design of the collimator shown in K030487 ..
- Indications for Use (intended use): Intended for use in diagnostic or fluoroscopic applications. 3.
- Description of the Device: This is a compact collimator with an external cover in ABS plastic. It is ব a single-layer, square field radiological collimator. Its light weight and compact size allow cass. positioning and make it ideal for mobile and portable units. The X-ray field size is limited by two pairs of lead shutters controlled by two knobs located on the sides of the collimator and by o yead disc near the x-ray focus to reduce scattered radiation. An indexed scale provides information on the field set with the knobs.
- 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. This device is identical to the predicate device made with the same components and specifications. The 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 R 72B 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 devise,
Image /page/0/Picture/9 description: The image shows a square-shaped object with a circular opening on top. The object appears to be made of a rough material, possibly concrete or stone. There are several small, dark circles visible on the sides of the object, which could be holes or indentations. The overall impression is that of a solid, industrial-looking structure.
1
Image /page/1/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the circle is a stylized image of a bird, possibly an eagle, with its wings spread. The bird is composed of three curved lines, giving it a modern and abstract appearance.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Lumos, Inc. (formerly Ralco, Inc.) % Mr. Daniel Kamm Principal Consultant Kamm & Associates 8726 Ferrara Ct. NAPLES FL 34114
Re: K093596
Trade/Device Name: Model R 72B Manual Collimator Regulation Number: 21 CFR 892.1610 Regulation Name: Diagnostic x-ray beam-limiting device Regulatory Class: II Product Code: KPW Dated: May 20, 2009 Received: November 25, 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 Amendmonts, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Or to 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, l'isting of devices, good manufacturing practice, labeling, and prohibitions against misburoning 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 coax 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. Your 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
JAN 1 2 2010
2
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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
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/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K093 (x)
Device Name: Model R 72B Manual Collimator
Indications For Use:
Model R 72B Manual X-RAY Collimator is intended for use in diagnostic radiographic or
fluoroscopic applications 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 Device Evaluation (ODE)
Heler Rumen
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number.
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