• FDA 510(k) records for OLYMPUS DISTAL ATTACHMENT, MODELS MH-462,-463,-464,-465,-466,-483,-587,-588,-589,-590,-591,-592,-593,-594,-595,-596,-597 K984358
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FDA 510(k) K202518, Promaxo MRI System, by Promaxo, Inc.

FDA 510(k) K202518, Promaxo MRI System, by Promaxo, Inc.

$89.00 USD
$89.00 USD
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FDA 510(k) records for Promaxo MRI System (K202518), submitted by Promaxo, Inc..

  • 510(k) Number: K202518
  • Device Classification: System, Nuclear Magnetic Resonance Imaging
  • Applicant: Promaxo, Inc.
  • Date Received: 09/01/2020
  • Decision Date: 03/03/2021
  • Decision: Substantially Equivalent (SESE)
  • Regulation Number: 892.1
  • Product Code: LNH
  • Subsequent Product Code: MOS
  • Regulation Medical Specialty: Radiology
  • Review Panel: Radiology
  • Total Pages: 61 (50 unredacted, 18% redacted overall)

What's in this document (sections may appear in any order):

  • — 510(k) Summary / Statement: no distinct section found
  • ✓ Indications for Use: 0% redacted
  • — Device Description: no distinct section found
  • ✗ Substantial Equivalence / Predicate: 100% redacted
  • — Performance / Bench Testing: no distinct section found
  • — Biocompatibility: no distinct section found
  • — Software / Cybersecurity: no distinct section found
  • — Sterilization / Shelf Life: no distinct section found
  • — Labeling / IFU: no distinct section found
  • — Clinical Data: no distinct section found
  • — FDA Correspondence: no distinct section found
  • — Risk Analysis / FMEA: no distinct section found
  • — Electromagnetic Compatibility (EMC): no distinct section found

Section contents and redaction percentages are AI-assisted estimates based on automated document analysis. Actual content may vary.

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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