FDA 510(k), K220205, 3D Anatomic Models

FDA 510(k), K220205, 3D Anatomic Models

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510(K) Number: K220205
Device Name: 3D Anatomic Models
Manufacturer: Ricoh USA, Inc.
Device Classification Name: System, Image Processing, Radiological
Regulation Number: 892.2050
Classification Product Code: LLZ
Date Received: 01/25/2022
Decision Date: 06/03/2022
Regulation Medical Specialty: Radiology

169 pages (688 of 857 original pages are fully redacted)

PLEASE NOTE: Most 510(k)s obtained through FOIA are heavily redacted, often omitting sections related to testing, software, manufacturing, and other technical data. Please be sure to review the total pages, redacted pages, and content pages listed in the description to get a sense of how much of the document is redacted. As the FDA FOIA office explains: “We HEAVILY REDACT the majority of the following portions of 510(k) filings: testing data, technical data, lab reports, manufacturing information, vendor information, substantive discussions regarding deficiencies or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.” If you’d like more details about a specific document before purchasing, please contact us at info@foiadocs.com.

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