← Product Code [IZH](/productcode/IZH) · K973400 # MAMMOTEST ADAPTER DRIVER (K973400) _Fischer Imaging Corp. · IZH · Nov 10, 1997 · Radiology · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K973400 ## Device Facts - **Applicant:** Fischer Imaging Corp. - **Product Code:** [IZH](/productcode/IZH.md) - **Decision Date:** Nov 10, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.1710 - **Device Class:** Class 2 - **Review Panel:** Radiology ## Indications for Use Adaptation for use on the Mammotest® System tables when the clinician wishes to use the Auto Suture ABBI* System for large core biopsy. ## Device Story The Mammotest® Adapter Driver is an accessory component designed for integration with Mammotest® System tables. It functions as an interface to enable the use of the Auto Suture ABBI* System for large core biopsy procedures. The device is operated by clinicians in a clinical setting. By facilitating the attachment of the ABBI* System to the existing Mammotest® table, it allows the clinician to perform biopsy procedures using the established imaging and positioning capabilities of the Mammotest® platform, thereby supporting diagnostic tissue sampling. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Mechanical adapter/driver component designed for physical integration with Mammotest® System tables to support the Auto Suture ABBI* System. No electronic, software, or energy-based components described. ## Regulatory 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. ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows a logo for the Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" written around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread. The eagle is facing to the right. Re: Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Samuella D. Emrich Director of Regulatory of Affairs Quality Assurance Fischer Imaging Corporation 12300 North Grant St. Denver, CO 80241 K973400 Mammotest® Adapter Driver Dated: August 1, 1997 Received: September 9, 1997 Regulatory class: II 21 CFR 892.1710/Procode: 90 IZH NOV 10 1997 Dear Mr. Emrich: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the interestone) to 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). You may, therefore, 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 either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivation assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations. This letter will allow you to begin marketing your device as described in your 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 Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours. N'Kiau Yu Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {1}------------------------------------------------ Initial 510(k) Mammotest® Adapter Driver Device Name: Adaptation for use on the Mammotest® System tables when the Indications for Use: clinician wishes to use the Auto Suture ABBI* System for large core biopsy. Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) Over-the-Counter Use__________________________________________________________________________________________________________________________________________________________ David L. Ingram --- (Division Sign-Off) OR Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number K973400 --- **Source:** [https://fda-staging.innolitics.com/device/K973400](https://fda-staging.innolitics.com/device/K973400) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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