The MDE NPRM did not propose a general exception for diagnostic equipment that was not capable of meeting the MDE Standards. As described in Section IV.A.1....
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M201.2 General Exception (Section-by-Section Analysis)
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M101.4 Equivalent Facilitation (Section-by-Section Analysis)
The MDE NPRM proposed to permit the use of alternative designs or technologies that are substantially equivalent to or provide greater accessibility and usability than strict compliance...
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M307 Operable Parts
M307 provides technical criteria for operable parts used by patients to activate, deactivate, or adjust the diagnostic equipment (see defined terms in M102.1)....
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A. Medical equipment and furniture
Medical equipment and furniture Without accessible medical examination tables, dental chairs, radiological diagnostic equipment, scales, and rehabilitation equipment, individuals with...
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Chapter M3 Technical Criteria
Chapter M3 provides technical criteria for accessible diagnostic equipment based on the patient positions that the equipment is designed to support, including equipment used by patients...
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Hologic - Breast Ultrasound, MRI and Tomosynthesis
Tools to spot, diagnose and treat cancer in women were among the products highlighted by Hologic Inc. during the 2010 RSNA show in Chicago.
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Chapter 3: Technical Requirements
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Chapter 1: Application and Administration
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I. Executive Summary
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Chapter M3: Technical Criteria
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M101.3 Equivalent Facilitation
The use of alternative designs or technologies that result in substantially equivalent or greater accessibility and usability than specified in the standards is permitted.
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Chapter M1: Application and Administration
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6. Regulatory Analyses
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1. General Exception
compliance with the proposed MDE Standards due to the location of imaging and mechanical components necessary to achieve the diagnostic aims....
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B. Regulatory Flexibility Act
The MDE Standards do not impose any mandatory requirements on any entity, including small entities....
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B. Chapter 2: Scoping (Section-by-Section Analysis)
In the final rule, Chapter 2 establishes that the enforcing authority will determine the number and types of diagnostic equipment to which the MDE Standards will apply....
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M305 Supports
The technical criteria for transfer supports are discussed under M301 Diagnostic Equipment Used by Patients in Supine, Prone, or Side-Lying Position and M302 Diagnostic Equipment Used by...
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Operable Parts
Components of diagnostic equipment that are used by the patient to activate, deactivate, or adjust the equipment....
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Operable Parts
A component of diagnostic equipment that is used by the patient to activate, deactivate, or adjust the equipment....
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IV. Significant Changes to the NPRM
This section of the preamble addresses significant changes made from the MDE NPRM to the final rule in response to the comments received, recommendations from the MDE Advisory Committee,...
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M303 Diagnostic Equipment Used by Patients Seated in a Wheelchair
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M303 Diagnostic Equipment Used by Patients Seated in a Wheelchair
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M101.5 Dimensions
The MDE Standards are based on adult dimensions and anthropometrics. Dimensions that are not stated as “maximum” or “minimum” are absolute....
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11B-805.4.2 Equipment
Clear space complying with Section 11B-305.2 shall be provided as required for specific equipment....
