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Cdr Systems Precision Patient Positioning System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K122888

by CDR Systems Inc

Identifiers

510(k) Number
K122888 FDA 510(k)
FDA Product Code
IYE FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.5050 FDA 510(k)
Regulation Number
892.5050 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Cdr Systems Precision Patient Positioning System by CDR Systems Inc — Class II — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
CDR Systems Inc
FDA Applicant
Cdr Systems, Inc.

Sources (1)

  • FDA 510(k) K122888 24 fields · synced Jun 18, 2026