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To provide a platform to conduct minimally invasive breast biopsy procedures.

A biopsy system, which uses x-ray guidance for stereotactic localization, that allows the physician to accurately place a biopsy needle for the retrieval of tissue samples in the area of concern. The tissue removed will require further evaluation through pathological assessment.

The system, in combination with the Kuske Breast Applicator Set and the Comfort Catheter System, can also be used as a table platform to perform Interstitial Brachytherapy procedures. The Kuske Breast Applicator Set and the Comfort Catheter System are stand alone items that do not attach to the system. The table platform is utilized as a means to image the area of interest and to image the template for placement of the catheters.

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I am sorry, but the provided text is a 510(k) clearance letter for the MammoTest® device and not a study report. It does not contain the detailed information about acceptance criteria and study results you requested. Therefore, I cannot generate the specific table and answer the questions based on the input.

The document primarily states that the FDA has reviewed the device and found it substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It also lists the indications for use of the MammoTest® system.

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The MammoPath can be used with Mammotest® (K861692). Mammotest is a breast biopsy system manufactured by Fischer Imaging, Inc., a dedicated Mammographic device for stereotactically - guided needle biopsy of the breast. Mammotest allows the operator to visualize suspicious breast lesions under Mammographic X-Ray and to guide various tissue acquisition devices to the lesion for tissue harvesting. The Mammopath would then be used for digital imaging of the harvested specimen to provide rapid verification that the correct tissue has been excised during biopsy.

The MammoPath can also be used as a stand-alone unit (without Fischer's Mammotest) and would be used to verify correct tissue sampling any given harvested specimen.

Doing the verification directly in the same room enables cases to be completed faster, thus limiting the time the patient needs to be under examination. Specimen radiography can potentially limit number of patient recalls.

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This document is a 510(k) clearance letter from the FDA for a device called "Mammopath™". It acknowledges the company's intent to market the device and determines it substantially equivalent to legally marketed predicate devices. However, the letter does not contain any information about acceptance criteria, study details, performance data, sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based only on the provided text. The document is solely a regulatory clearance and does not include the detailed technical or clinical study data.

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The LC positioner is to be used as an accessory to a fluoroscopic unit for imaging the cardiovascular system.

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This document is a 510(k) premarket notification letter from the FDA regarding a device called the "LC Positioner (Fluoro C-Arm)". It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert evaluations.

The letter primarily:

• Confirms that the device is substantially equivalent to legally marketed predicate devices.
• Classifies the device as Class II (21 CFR 892.1650/Procode: 90 JAA).
• Outlines post-market regulatory requirements (e.g., general controls, GMP, labeling).

Attachment A provides the device name and its intended use: "The LC positioner is to be used as an accessory to a fluoroscopic unit for imaging the cardiovascular system."

Therefore, based solely on the provided text, I cannot answer the questions regarding acceptance criteria and device performance studies.

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Adaptation for use on the Mammotest® System tables when the clinician wishes to use the Auto Suture ABBI* System for large core biopsy.

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This document is a 510(k) clearance letter from the FDA for a device called "Mammotest® Adapter Driver." It acknowledges that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information regarding acceptance criteria, device performance, study details, sample sizes, expert qualifications, ground truth establishment, or any of the other specific study-related information requested in the prompt.

The letter is a regulatory approval, not a technical report or a study summary. It confirms the device's clearance for marketing based on substantial equivalence, but it does not detail the technical performance studies that might have been submitted to support that claim.

Therefore, I cannot provide the requested table and study information based solely on the provided text. To answer your questions, I would need a different document, such as a summary of safety and effectiveness (SSE) or the full 510(k) submission, which would contain the technical data and study details.

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Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device