(94 days)
K941353/S1
K941353/S1
No
The description focuses on the automatic selection of a physical filter based on breast density, not on image analysis or algorithmic decision-making typically associated with AI/ML in medical imaging.
No
The device is a mammography system, used for imaging and diagnosis, not for treating a condition.
No
This device is a mammography system that produces images; it does not explicitly state that it diagnoses conditions from these images. Its function is to acquire images, specifically of breasts.
No
The device description explicitly states the addition of an "optional filter assembly (including molybdenum and rhodium filters)" which are hardware components.
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 Description: The description clearly states that this is a modification to a mammography system. Mammography is an imaging technique that uses X-rays to examine the breasts. It is an in vivo (performed on a living organism) diagnostic method, not an in vitro one.
- Intended Use: The intended use is for imaging breasts, which is consistent with an in vivo diagnostic procedure.
- Input Imaging Modality: The input modality is explicitly stated as mammography.
Therefore, this device falls under the category of medical imaging equipment used for in vivo diagnosis, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
the intended use and the indications of use of the MAM-CH22S with the Automatic Filter Selection Option are identical to those of the MAM-CH22S. With the Automatic Filter Selection mode, dense or thick breasts can be imaged with improved contrast and/or less radiation dose when the mammography system automatically selects the rhodium filter.
Product codes
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Device Description
modification of the legally marketed mammography system (K941353/S1) by the addition of the optional filter assembly (including molybdenum and rhodium filters) and its automatic mode of operation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
mammography
Anatomical Site
breasts
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K941353/S1
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1710 Mammographic x-ray system.
(a)
Identification. A mammographic x-ray system is a device intended to be used to produce radiographs of the breast. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
APR 2 9 1996
SUMMARY OF SAFETY AND EFFECTIVENESS
The 510(k) premarket notification for the Automatic Filter Selection Option for the MAM-CH22S mammography system describes a modification of the legally marketed mammography system (K941353/S1) by the addition of the optional filter assembly (including molybdenum and rhodium filters) and its automatic mode of operation.
With reqards to effectiveness, the intended use and the indications of use of the MAM-CH22S with the Automatic Filter Selection Option are identical to those of the MAM-CH22S. With the Automatic Filter Selection mode, dense or thick breasts can be imaged with improved contrast and/or less radiation dose when the mammography system automatically selects the rhodium filter.
With regards to safety, the MAM-CH22S mammography system with the Automatic Filter Selection Option was designed to comply with International Standard IEC (International Electrotechnical Commission) 601-1. Medical Electrical Equipment, Part 1: General Requirements For Safety, The modification was analyzed and preventive measures were taken.
Based on this analysis, to the best of our judgment, the addition of the Automatic Filter Selection Option modification to the MAM-CH22S mammography system. does not add a significant risk that can cause a safety hazard.
Based on the above, it is Elscint's opinion that the MAM-CH22S mammography system with the Automatic Filter Selection Option, is substantially equivalent in safety and effectiveness to the legally marketed device, MAM-CH22S.