{"filing":{"accession_number":"0001213900-26-061008","cik":"0001833498","ticker":"MDAIW","company_name":"Spectral AI, Inc.","form":"8-K","filing_date":"2026-05-26","report_date":null,"primary_document":"ea0292182-8k_spectral.htm","primary_document_url":"https://www.sec.gov/Archives/edgar/data/1833498/000121390026061008/ea0292182-8k_spectral.htm"},"events":[{"id":9061,"run_id":7956,"accession_number":"0001213900-26-061008","anchor_item_number":null,"event_type":"other_material","event_domain":"catchall","is_material":true,"confidence":0.75,"summary":"Spectral AI announced on May 26, 2026 that the FDA granted De Novo Classification for its DeepView® System, authorizing commercial distribution in the United States. This is a material regulatory milestone that enables the company to commercialize a key product, but it does not fit neatly into the standard 8-K event taxonomy (not an earnings release, M\u0026A activity, executive change, impairment, or other specifically enumerated category). The De Novo pathway is a significant regulatory achievement for a medical device company that would affect investor assessment of commercialization prospects.","company_name":"Spectral AI, Inc.","ticker":"MDAIW","filing_date":"2026-05-26","form":"8-K","submitted_at":null,"items":null}],"classifications":[{"id":1548,"accession_number":"0001213900-26-061008","item_number":null,"item_title":null,"event_type":"other_material","event_domain":"catchall","is_material":true,"confidence":0.75,"reasoning":"Spectral AI announced on May 26, 2026 that the FDA granted De Novo Classification for its DeepView® System, authorizing commercial distribution in the United States. This is a material regulatory milestone that enables the company to commercialize a key product, but it does not fit neatly into the standard 8-K event taxonomy (not an earnings release, M\u0026A activity, executive change, impairment, or other specifically enumerated category). The De Novo pathway is a significant regulatory achievement for a medical device company that would affect investor assessment of commercialization prospects.","classifier_version":"claude-haiku-4-5-20251001+prompt-9e0ffca5","taxonomy_version":"v1","classified_at":"2026-05-27T02:13:57.943423+00:00","company_name":"Spectral AI, Inc.","ticker":"MDAIW","filing_date":"2026-05-26"}]}