FDA 510(k), K221241, DrAid for Radiology v1

FDA 510(k), K221241, DrAid for Radiology v1

Regular price $89.00 USD
Regular price Sale price $89.00 USD
Sale Sold out
510(K) Number: K221241
Device Name: DrAid for Radiology v1
Manufacturer: Nguyen Nhat Linh
Device Classification Name: Radiological Computer-Assisted Prioritization Software For Lesions
Regulation Number: QFM
Classification Product Code: KXA
Date Received: 04/29/2022
Decision Date: 09/01/2022
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology

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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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.

View full details