(49 days)
Not Found
No
The description focuses on the hardware (x-ray system, cabinet geometry, focal spot, camera) and basic software for image acquisition and DICOM compliance. There is no mention of AI, ML, or advanced image processing techniques that would typically indicate the use of such technologies. The performance studies focus on compliance with cabinet x-ray system standards and electrical safety, not on algorithmic performance metrics common for AI/ML devices.
No
The device is described as a "Specimen Radiography System" used to image harvested specimens for verification purposes. Its function is diagnostic imaging of excised tissue, not directly treating a patient or restoring health.
No
Explanation: The device is used to provide rapid verification that the correct tissue has been excised during a biopsy procedure. While it aids in verification, it does not diagnose a condition or disease in a patient. Its function is to confirm the presence of specific tissue after it has been excised, which is a procedural verification rather than a diagnostic process.
No
The device description clearly states it is a "Cabinet X-ray System" and includes hardware components like an integrated camera and supports radiographic film. It is not solely software.
Based on the provided information, the MX-20 is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- MX-20 Function: The MX-20 is a cabinet x-ray system used to create images of harvested specimens to verify that the correct tissue has been excised. It is a tool for imaging the specimen after it has been removed from the body.
- No Analysis of Biological Properties: The device does not analyze the biological or chemical properties of the specimen itself to provide diagnostic information about a patient's health. It provides a visual image for verification purposes.
- Focus on Imaging, Not Diagnosis: The intended use is for "rapid verification that the correct tissue has been excised," not for diagnosing a disease or condition based on the specimen's characteristics.
While the device is used with biological specimens, its function is to provide an image, not to perform an in vitro diagnostic test on the specimen.
N/A
Intended Use / Indications for Use
The MX-20 is a Cabinet x-ray system that is used to provide film and/or digital x-ray images of harvested specimens from various anatomical regions in order to provide rapid verification that the correct tissue has been excised during the biopsy procedure.
Doing the verification directly in the same room or nearby enables cases to be completed faster, thus limiting the time the patient needs to be under examination. Specimen radiography can potentially limit the number of patient recalls.
Product codes (comma separated list FDA assigned to the subject device)
MWP
Device Description
The Faxitron MX-20 Specimen Radiography System is a Cabinet X-ray System specifically designed to provide high detail radiographic imaging of surgically excised medical specimens. The exceptionally high magnification capability (up to 5X) from the 0.02 mm focal spot with optimized cabinet geometry and the superior contrast available from the low kV capability provides enhanced film and/or digital imaging performance. This device supports radiographic film sizes up to 30 x 35 cm and can be configured to acquire high resolution, DICOM compliant, digital x-ray images through the use of an integrated camera and Faxitron Specimen Radiography software.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
X-ray
Anatomical Site
various anatomical regions
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
The MX-20 Specimen Radiography System is a Cabinet X-ray System and has been designed and tested to comply with the performance standards set forth in 21 CFR 1020.40 Cabinet X-ray Systems. Testing and performance data pertaining to this standard has been included as part of the submission. This device has also been tested for electrical safety and is Classified by Underwriters Laboratories in the US and Canada. Additional testing to certify compliance to the European Low voltage and EMC directives has been successfully completed and documented in this submission.
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
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only 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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KC72557
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Image /page/0/Picture/1 description: The image shows the logo for Faxitron X-Ray Corporation. The logo is in black and white and features the company name in a bold, sans-serif font. The word "Faxitron" is larger than "X-Ray" and is placed above the company's name.
007 3002007
PREMARKET NOTIFICATION 510 (k) Summary As required by 21 CFR 807.92
Device name – as required by 807.92(a)(2):
| Trade Name: | Faxitron MX-20 Specimen Radiography System |
|---|---|
| Common/Classification Name: | Specimen x-ray System/Cabinet X-ray System |
| Classification Regulation: | 21 CFR 892.1680 |
| Device Class: | Class II |
| Product Code (Procode): | MWP |
| Panel: | Radiologic Devices Panel |
| Premarket Notification submitter: | |
| Company Name: | Faxitron X-ray Corporation |
| Company Address: | 225 Larkin Drive, Suite 1 |
| Wheeling, II 60090-7209 | |
| Contact: | Douglas C. Wiegman, |
| VP Engineering and Regulatory Affairs | |
| Preparation Date: | September 6, 2007 |
A. LEGALLY MARKETED PREDICATE DEVICES – as required by 21 CFR 807.92(a)(3)
The Faxitron MX-20 Digital Specimen Radiography System is substantially equivalent to the following to the following predicate devices:
Ο Faxitron Micro 50 Specimen Radiography System-K852634
Ο Faxitron DX-50 Digital Radiography System-K061361
| Faxitron X-ray Corporation | MX-20 510(k) Submission | Page 9 of 30 |
|---|---|---|
| ---------------------------- | ------------------------- | -------------- |
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- o piXarray Digital Specimen Radiography System-K052433
- B. DEVICE DESCRIPTION as required by 21 CFR 807.92(a)(4)
The Faxitron MX-20 Specimen Radiography System is a Cabinet X-ray System specifically designed to provide high detail radiographic imaging of surgically excised medical specimens. The exceptionally high magnification capability (up to 5X) from the 0.02 mm focal spot with optimized cabinet geometry and the superior contrast available from the low kV capability provides enhanced film and/or digital imaging performance. This device supports radiographic film sizes up to 30 x 35 cm and can be configured to acquire high resolution, DICOM compliant, digital x-ray images through the use of an integrated camera and Faxitron Specimen Radiography software.
-
C. DEVICE CLAIMS as required by 807.92(a)
The Faxitron MX-20 Specimen Radiography System is a fully shielded Cabinet X-ray System that has been designed to comply with 21 CFR 1020.40. The system allows up to 5 times geometric magnification of excised specimens with minimal qeometric distortion through the use of a focal spot size that is less than 20 microns. The x-ray coverage of the device allows the use of radiographic film sizes up to 30 x 35 cm. The device can also be configured to provide high resolution, DICOM compliant, digital images through the use an integrated digital camera and Faxitron Specimen Radiography software. The Faxitron Software supports the DICOM Store, Print and Modality Worklist services. -
D. DEVICE TECHNICAL SPECIFICATIONS as required by 807.92(a)(4)
Cabinet Specifications: -
o Energy Range: 10-35 kV
-
Tube Current: 300 µA o
-
Focal Spot Size: