Week of June 30, 2026

New FDA decisions (7)

• Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012)

  K253628 · Agada Medical, Ltd. · June 29, 2026

  Agada Medical, Ltd. is listed for Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012) (K253628). The FDA list gives June 29, 2026 as the date of the final decision. The lead panel is Radiology, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code QIH as “Automated Radiological Image Processing Software”: To provide automated radiological image processing and analysis tools. Software implementing artificial intelligence including nonadaptive machine learning algorithms trained with clinical and/or artificial data. In these devices, the algorithm training data typically impacts device performance. Adaptive AI algorithms are not within scope of this product code. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253628

• ADAS 3D

  K253969 · Adas3D Medical S.L. · June 29, 2026

  Adas3D Medical S.L. is listed for ADAS 3D (K253969). The FDA list gives June 29, 2026 as the date of the final decision. The lead panel is Radiology, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code QIH as “Automated Radiological Image Processing Software”: To provide automated radiological image processing and analysis tools. Software implementing artificial intelligence including nonadaptive machine learning algorithms trained with clinical and/or artificial data. In these devices, the algorithm training data typically impacts device performance. Adaptive AI algorithms are not within scope of this product code. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253969

• Alturion Series Diagnostic Ultrasound System

  K260667 · Philips Ultrasound, LLC · June 29, 2026

  Philips Ultrasound, LLC is listed for Alturion Series Diagnostic Ultrasound System (K260667). The FDA list gives June 29, 2026 as the date of the final decision. The lead panel is Radiology, and the database link on the FDA list is the 510(k) pathway. The primary product code on the FDA list is IYN. openFDA did not return a classification record for that code in this copy of the data. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260667

• SOMNUM (SOMNUM)

  K253390 · Honeynaps Co., Ltd. · June 27, 2026

  Honeynaps Co., Ltd. is listed for SOMNUM (SOMNUM) (K253390). The FDA list gives June 27, 2026 as the date of the final decision. The lead panel is Neurology, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code OLZ as “Automatic Event Detection Software For Polysomnograph With Electroencephalograph”: Automatically mark electroencephalograph and polysomongraph signals in order to aid in identification of such events and annotation of prolonged PSG traces; Automatically calculate simple measures obtained from recorded signals (e.G. Magnitude, time, frequency and simple statistical measures of marked events); All output subject to verification by qualified user openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253390

• MammoScreen® (5)

  K260714 · Therapixel · June 26, 2026

  Therapixel is listed for MammoScreen® (5) (K260714). The FDA list gives June 26, 2026 as the date of the final decision. The lead panel is Radiology, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code QDQ as “Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer”: A radiological computer assisted detection and diagnostic software for suspected lesions is an image processing device intended to aid in the detection, localization, and characterization of lesions suspicious for cancer on acquired medical images (e.g., mammography , MR, CT, ultrasound, radiography). The device detects, identifies and characterizes lesions suspicious for cancer based on features or information extracted from the images, and may provide information about the presence, location, and characteristics of the lesion to the user. Primary diagnostic and patient management decisions are made by the clinical user. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K260714

• syngo.CT Coronary Cockpit

  K253786 · Siemens Medical Solutions USA, Inc. · June 25, 2026

  Siemens Medical Solutions USA, Inc. is listed for syngo.CT Coronary Cockpit (K253786). The FDA list gives June 25, 2026 as the date of the final decision. The lead panel is Radiology, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code QIH as “Automated Radiological Image Processing Software”: To provide automated radiological image processing and analysis tools. Software implementing artificial intelligence including nonadaptive machine learning algorithms trained with clinical and/or artificial data. In these devices, the algorithm training data typically impacts device performance. Adaptive AI algorithms are not within scope of this product code. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253786

• Enhanced Boundary for PCCT

  K253560 · Ge Medical Systems, LLC · June 24, 2026

  Ge Medical Systems, LLC is listed for Enhanced Boundary for PCCT (K253560). The FDA list gives June 24, 2026 as the date of the final decision. The lead panel is Radiology, and the database link on the FDA list is the 510(k) pathway. The primary product code on the FDA list is JAK. openFDA did not return a classification record for that code in this copy of the data. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253560

Regulatory documents (0)

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Prior-auth milestones (0)

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Comment deadlines (1)

• Request for Information (RFI): Pharmacy Benefit Manager Compensation and Data Collection

  Comments close July 20, 2026

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