K252653
- 510(k) number
- K252653
- Device name
- ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single Transducer Cable; Triple Transducer Cable
- Applicant
- Acist Medical Systems, Inc. MN · US
- Product code
- DXT — Injector And Syringe, Angiographic
- Decision date
- 2026-05-13
- Date received
- 2025-08-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.8 MB · U.S. public domain
Also available from FDA: K252653.pdf
Official FDA record: K252653
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.