{"product_id":"fda-510k-k202518-promaxo-mri-system","title":"FDA 510(k) K202518, Promaxo MRI System, by Promaxo, Inc.","description":"\u003cp\u003eFDA 510(k) records for \u003cstrong\u003ePromaxo MRI System\u003c\/strong\u003e (K202518), submitted by Promaxo, Inc..\u003c\/p\u003e\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003e510(k) Number:\u003c\/strong\u003e K202518\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDevice Classification:\u003c\/strong\u003e System, Nuclear Magnetic Resonance Imaging\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eApplicant:\u003c\/strong\u003e Promaxo, Inc.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDate Received:\u003c\/strong\u003e 09\/01\/2020\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDecision Date:\u003c\/strong\u003e 03\/03\/2021\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eDecision:\u003c\/strong\u003e Substantially Equivalent (SESE)\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eRegulation Number:\u003c\/strong\u003e 892.1\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eProduct Code:\u003c\/strong\u003e LNH\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSubsequent Product Code:\u003c\/strong\u003e MOS\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eRegulation Medical Specialty:\u003c\/strong\u003e Radiology\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eReview Panel:\u003c\/strong\u003e Radiology\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eTotal Pages:\u003c\/strong\u003e 61 (50 unredacted, 18% redacted overall)\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp\u003e\u003cstrong\u003eWhat's in this document\u003c\/strong\u003e (sections may appear in any order):\u003c\/p\u003e\u003cul\u003e\n\u003cli\u003e— \u003cstrong\u003e510(k) Summary \/ Statement:\u003c\/strong\u003e no distinct section found\u003c\/li\u003e\n\u003cli\u003e✓ \u003cstrong\u003eIndications for Use:\u003c\/strong\u003e 0% redacted\u003c\/li\u003e\n\u003cli\u003e— \u003cstrong\u003eDevice Description:\u003c\/strong\u003e no distinct section found\u003c\/li\u003e\n\u003cli\u003e✗ \u003cstrong\u003eSubstantial Equivalence \/ Predicate:\u003c\/strong\u003e 100% redacted\u003c\/li\u003e\n\u003cli\u003e— \u003cstrong\u003ePerformance \/ Bench Testing:\u003c\/strong\u003e no distinct section found\u003c\/li\u003e\n\u003cli\u003e— \u003cstrong\u003eBiocompatibility:\u003c\/strong\u003e no distinct section found\u003c\/li\u003e\n\u003cli\u003e— \u003cstrong\u003eSoftware \/ Cybersecurity:\u003c\/strong\u003e no distinct section found\u003c\/li\u003e\n\u003cli\u003e— \u003cstrong\u003eSterilization \/ Shelf Life:\u003c\/strong\u003e no distinct section found\u003c\/li\u003e\n\u003cli\u003e— \u003cstrong\u003eLabeling \/ IFU:\u003c\/strong\u003e no distinct section found\u003c\/li\u003e\n\u003cli\u003e— \u003cstrong\u003eClinical Data:\u003c\/strong\u003e no distinct section found\u003c\/li\u003e\n\u003cli\u003e— \u003cstrong\u003eFDA Correspondence:\u003c\/strong\u003e no distinct section found\u003c\/li\u003e\n\u003cli\u003e— \u003cstrong\u003eRisk Analysis \/ FMEA:\u003c\/strong\u003e no distinct section found\u003c\/li\u003e\n\u003cli\u003e— \u003cstrong\u003eElectromagnetic Compatibility (EMC):\u003c\/strong\u003e no distinct section found\u003c\/li\u003e\n\u003c\/ul\u003e\u003cp\u003e\u003cem\u003eSection contents and redaction percentages are AI-assisted estimates based on automated document analysis. Actual content may vary.\u003c\/em\u003e\u003c\/p\u003e","brand":"FDA","offers":[{"title":"Default Title","offer_id":51454814126244,"sku":"FDA510K202518","price":89.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0659\/0677\/0084\/files\/fda_510k_icon_d2ceddf6-038e-41ac-b109-d79200a9a781.png?v=1786210400","url":"https:\/\/foiadocs.com\/products\/fda-510k-k202518-promaxo-mri-system","provider":"FOIA Document Source","version":"1.0","type":"link"}