21 CFR 882.4565
§ 882.4565 Field generator positioning device.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 882.4565, § 882.4565 Field generator positioning device, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90702
- Permanent ID
ys:prov:90702@1- SHA-256
4788b7022b0c07d3f230b93b5ab1fc34233ac7c5d39cfada479819eff77d361c
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Full text
(a) Identification. A field generator positioning device is a manual, mechanical device intended to position the field generator of an electromagnetic based stereotaxic navigation system in proximity to a patient. The device may operate independently or adapt existing medical equipment, such as a procedure chair or surgical bed, by using a mechanical interface.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.