(159 days)
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Not Found
No
The summary describes a mechanical collimator for limiting the x-ray field, with no mention of AI/ML, image processing, or performance studies typically associated with AI/ML devices.
No
The device is described as being for "diagnostic use" and is intended to limit radiation exposure during x-ray imaging, not to treat a medical condition.
Yes
The "Intended Use / Indications for Use" section explicitly states, "This device is for diagnostic use."
No
The device description explicitly states it is a "collimator," which is a physical hardware component used with an x-ray generator and tube. There is no mention of software as the primary or sole component.
Based on the provided information, 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.
- Device Function: The description clearly states the device is a collimator used in radiology with an x-ray generator and tube. Its purpose is to limit the area of radiation emitted during an x-ray procedure.
- No Sample Analysis: There is no mention of the device analyzing any biological samples from a patient. Its function is purely related to controlling the physical beam of radiation.
Therefore, this device falls under the category of a medical device used in imaging, but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Page 1 of 1
Indication for Use:
/ This device is intended to be used in radiology.
This collimator is to be used in conjunction with an x-ray generator and x-ray tube / to limit the area of radiation that is emitted to a confined field of view. This limits the potential for radiation to the general population in the exam area.
- / This device is for diagnostic use.
This device is operated and used by Physicians and X-Ray technologist. /
/ The object of this device is total patient populations.
Product codes
IZW, IZX
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
x-ray
Anatomical Site
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Indicated Patient Age Range
total patient populations.
Intended User / Care Setting
Physicians and X-Ray technologist.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Not Found
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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
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
Shimadzu Corporation % Mr. Don Karle Director, National Service Shimadzu Medical Systems 20101 South Vermont Avenue TORRANCE CA 90502-1328
Re: K101039
SHIP 2 0 2010
Trade/Device Name: R-300 Regulation Number: 21 CFR 892.1610 Regulation Name: Diagnostic x-ray beam-limiting device Regulatory Class: II Product Code: IZW and IZX Dated: April 2, 2010 Received: April 15, 2010
Dear Mr. Karle:
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,
Donald J. Trump
Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Page 18
Section XI. INDICATION FOR USE
Page 1 of 1
| 510(K) number (if known): | Unknown |
|---|---|
| Device Name: | R-300 |
| SEP 20 2010 |
Indication for Use:
/ This device is intended to be used in radiology.
This collimator is to be used in conjunction with an x-ray generator and x-ray tube / to limit the area of radiation that is emitted to a confined field of view. This limits the potential for radiation to the general population in the exam area.
- / This device is for diagnostic use.
This device is operated and used by Physicians and X-Ray technologist. /
/ The object of this device is total patient populations.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter Use _
(Per 21CFR801 Subpart D)
(21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign Off)
Office of Ir
510K K101039