Slot Radiography Accurate measurements. Extra-wide Imagining Range. The combination of SONIALVISION G4's extra-long imaging chain slide coverage and 17” large FPD realizes even wider imaging coverage (Max.145cm × 42cm) than that of CR's image stitching. Air kerma and half-value layer were measured and Average Glandular Dose to the patient was calculated for a scanning multi-slit digital mammography system. Dose measurements on this type of system are non-trivial because of the lower dose-rate and the difference in irradiation geometry compared to conventional systems. Elizabeth Hospital offers screening digital mammography and DEXA bone density testing: Monday – Friday, 7 a.m. Open slots available one Saturday per month. You do not need a referral for your annual screening mammogram. Scheduling: 253-573-7320. Toll-free: 1-844-741-2722. 3D screening mammography and bone density screening (DEXA.

Slot Scanning Mammography Imaging

Document issued on: March 27, 2012

This document supersedes “Class II Special Controls Guidance Document: Full-Field Digital Mammography System,” issued November 5, 2010.

On April 4, 2012 this document was edited to correct formatting, and to clarify that equivalent mammography reader qualifications are also acceptable in Appendix A.

For questions regarding this document contact Mary Pastel (OIVD) at 301-796-6887 or by e-mail at Mary.Pastel@fda.hhs.gov or Kyle J. Myers (OSEL) at 301-796-2533 or by e-mail at Kyle.Myers@fda.hhs.gov.

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Division of Imaging and Applied Mathematics
Office of Science and Engineering Laboratories (OSEL)

Preface

Public Comment

You may submit written comments and suggestions at any time for Agency consideration to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, rm. 1061, (HFA-305), Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov. Identify all comments with the docket number listed in the notice of availability that publishes in the Federal Register. Comments may not be acted upon by the Agency until the document is next revised or updated.

Additional Copies

Additional copies are available from the Internet. You may also send an e-mail request to CDRH-Guidance@fda.hhs.gov to receive a copy of the guidance. Please use the document number 1616 to identify the guidance you are requsting.

Slot Scanning Mammography Center

DESCRIBING YOUR DEVICE IN A 510(K) PREMARKET NOTIFICATION
- INDICATIONS FOR USE
- DEVICE DESCRIPTION
- DESCRIPTIONS COMMON TO INTEGRATED DETECTOR AND DETECTOR-ONLY SYSTEMS
  - Detector
  - Flat Field Correction and Pixel Defects
  - Image Acquisition
- DESCRIPTIONS SPECIFIC TO INTEGRATED SYSTEMS
  - X-ray Unit
  - X-ray Tube
  - X-ray Generator
  - X-ray Anti-Scatter Grid
  - Breast Compression System
  - Principles of Operation
  - Software
- DESCRIPTIONS SPECIFIC TO DETECTOR-ONLY SYSTEMS
PHYSICAL LABORATORY TESTING
- SENSITOMETRIC RESPONSE
- SPATIAL RESOLUTION
- NOISE ANALYSIS
- SIGNAL-TO-NOISE RATIO TRANSFER - DQE
- DYNAMIC RANGE
- IMAGE ERASURE AND FADING
- REPEATED EXPOSURE TEST
- AUTOMATIC EXPOSURE CONTROL PERFORMANCE
- PHANTOM TESTING
- PATIENT RADIATION DOSE
- BREAST COMPRESSION SYSTEM
LABELING
- INDICATION FOR USE
- PRECAUTIONS
- DEVICE DESCRIPTION
- DEVICE INFORMATION
- SUMMARY OF PHYSICAL LABORATORY TESTING
- SUMMARY OF CLINICAL IMAGE EVALUATION
- DIRECTIONS FOR USE
- ADDITIONAL INFORMATION

Guidance for Industry and FDA Staff

Class II Special Controls Guidance Document: Full-Field Digital Mammography System

1. Introduction

The Food and Drug Administration (FDA) has developed this guidance as the special control to support the classification of full-field digital mammographic devices (FFDM) into class II (special controls). Full-field digital mammographic devices are either integrated systems that include both the x-ray delivery system and integrated (non-removable) detector, or detector-only (removable) systems intended to be used on existing x-ray systems where the removable detector, such as a computed radiography cassette replaces the film/screen detector. This guidance does not cover tomosynthesis or computed tomography breast imaging devices. FDA is issuing this guidance in conjunction with a Federal Register (FR) notice announcing the final rule classifying FFDM devices into class II (special controls). The classification regulation designates this guidance document as the special control for these devices.

Designation of this document as a special control means that, following the effective date of a final rule, any firm intending to market a new FFDM device will need to address the issues covered in this special controls guidance. The firm will need to show that its device addresses the issues of safety and effectiveness identified in this guidance, either by meeting the recommendations of this guidance or by some other means that provides equivalent assurances of safety and effectiveness.

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2. Background

FDA believes that special controls, when combined with the general controls of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), will be sufficient to provide reasonable assurance of the safety and effectiveness of full-field digital mammography devices. Thus a manufacturer who intends to market a device of this generic type must:

conform to the general controls of the FD&C Act, including the premarket notification requirements described in 21 CFR 807 Subpart E,
address the specific risks to health associated with full-field digital mammography devices identified in this guidance, and
obtain a substantial equivalence determination from FDA prior to marketing the device. (See 21 CFR 807 Subpart E, including 21 CFR 807.81 and 807.87).

This special control guidance identifies the classification regulation and product codes for full-field digital mammography devices (Please refer to Section 3, Scope). In addition, other sections of this special control guidance document list the risks to health identified by FDA and describe measures that, if followed by manufacturers and combined with the general controls, will generally address the risks associated with full-field digital mammography devices and lead to a timely 510(k) review.

This document supplements other FDA documents regarding the specific content requirements of a premarket notification (510(k)) submission. You should also refer to 21 CFR 807.87, the guidance entitled Format for Traditional and Abbreviated 510(k)s,¹ and the Premarket Notification 510(k) section of CDRH’s Device Advice web page.²

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3. Scope

The scope of this document is limited to FFDM systems³ in the proposed new regulation 21 CFR 892.1715, product code MUE.

21 CFR 892.1715 – Full-Field Digital Mammography System.

(a) Identification. A full-field digital mammography system is a device intended to produce planar digital x-ray images of the entire breast. This generic type of device may include digital mammography acquisition software, full field digital image receptor, acquisition workstation, automatic exposure control, image processing and reconstruction programs, patient and equipment supports, component parts, and accessories.

(b) Classification. Class II (special controls). The special control for the device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Full-Field Digital Mammography System.”⁴ See §892.1(e) for the availability of this document.

A mammography system usually consists of an x-ray generator, x-ray control, x-ray tube, collimator, beam filter, breast compression system, grid, image receptor system, and accessories. In the case of integrated FFDM systems, the image receptor system consists of a built-in full-field solid state detector, acquisition software, acquisition work station, and accessories. In the case of detector-only type FFDM systems, the image receptor system consists of a removable solid state detector, detector readout device, acquisition and readout software, acquisition work station, and accessories.

This guidance does not cover display acc