(41 days)
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No
The device description is "Fibre Interspaced X-ray grids" and there are no mentions of AI, DNN, or ML, nor any descriptions of training or test sets which are typical for AI/ML devices.
No
The device is described as "Fibre Interspaced X-ray grids," which are components used in X-ray imaging to improve image quality by reducing scatter radiation. They are not therapeutic in nature; their function is diagnostic imaging.
No
The device description "Fibre Interspaced X-ray grids" suggests a component used in X-ray imaging, specifically to improve image quality by absorbing scatter radiation. It does not describe a device that performs diagnosis or analyzes medical conditions.
No
The device description explicitly states "Fibre Interspaced X-ray grids," which are physical hardware components used in X-ray imaging. This indicates the device is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health.
- The device description "Fibre Interspaced X-ray grids" and the input imaging modality "X-ray" indicate that this device is used in conjunction with X-ray imaging, which is a diagnostic procedure performed on the body.
- There is no mention of analyzing biological specimens.
Therefore, this device falls under the category of a medical device used for imaging, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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Product codes (comma separated list FDA assigned to the subject device)
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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
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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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.
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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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 892.1910 Radiographic grid.
(a)
Identification. A radiographic grid is a device that consists of alternating radiolucent and radiopaque strips intended to be placed between the patient and the image receptor to reduce the amount of scattered radiation reaching the image receptor.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.
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smit röntgen
Postbox 218 5600 MD Eindhoven, The Netherlands Tel. 31.40.2762707 Fax. 31.40.2762478
Image /page/0/Picture/2 description: The image shows a logo with the word "Smit" in large, bold letters on the top line. Below "Smit" is the word "röntgen" in a smaller font size. The word "röntgen" is set against a horizontally striped background, which provides contrast and makes the text stand out. The overall design is simple and clean, with a focus on readability.
Department of Health and Human Services Center for Devices and Radiological Health Office of Device Evaluation Premarket Notification section
NOV - 7 1996
Smit Roentgen Approbation XB36150/96-09-26/RR/LS
XB 36150/RR/LS. 1996.09.26
SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
for
SMIT ROENTGEN FIBRE INTERSPACED X-RAY GRIDS
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirement of SMDA 1990
The undersigned certifies that the 510(k) Premarket Notification for the above referenced product contains adequate information and data to enable CDRH to determine substantial equivalence
The information is summarized as follows:
- 】. The Fibre Interspaced X-ray grids are subject to Federal Performance Standards, defined in 21CFR- 982.1910
- The Fibre Interspaced X-ray grids will be manufactured in accordance with voluntary 2. safety standards, such as IEC publication 627
- Past experience with substantially equivalent predicate devices has shown our device to 3. be safe and effective when properly used.
Ing. R.W. Rijntjes
Approbation Manager Smit Roentgen Eindhoven , The Netherlands