ACIST Pro Diagnostic System (019304) +5 more— 510(k) K252653
Substantially EquivalentAcist Medical Systems, Inc.
FDA 510(k) clearance K252653 for ACIST Pro Diagnostic System (019304) +5 more, Substantially Equivalent on 2026-05-13. Applicant: Acist Medical Systems, Inc.. Device class: 2.
Summary
Acist Medical Systems' record lists six items: the ACIST Pro Diagnostic System (019304), a Processing Unit Bed Mount, an AngioTouch Module, the ACIST Pro Cart, a Single Transducer Cable and a Triple Transducer Cable. The product code is DXT, angiographic injectors and syringes.
Class II, 21 CFR 870.1650. The General Hospital review panel handled it as a Traditional 510(k), though the record lists Cardiovascular as the classification panel.
Acist filed from Eden Prairie, Minnesota. The decision came 264 calendar days after receipt (August 22, 2025 to May 13, 2026).
Clearance details
- Device name as filed
- 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.
- Product code
- Product code DXT
- Device class
- Class 2
- Regulation
- 21 CFR 870.1650
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Eden Prairie, MN, US
Recent devices under product code DXT
view all- K262043 — MEDRAD® MRXperion MR Injection System and MR Injection System Syringe Kit +2 more
- K252652 — Disposable Syringes with Accessories for Power Injectors (7+ models)
- K252638 — VeraPro S100 Multi-Use Syringe (018808) +4 more
- K253048 — High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube
- K251788 — Extension tube
More clearances from Acist Medical Systems, Inc.
view all- K262115 — VueJect® Ultrasound Enhancing Agent Delivery System
- K233904 — ACIST RXi System (016616); ACIST Navvus II Catheter (016675_
- K203004 — ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System
- K193183 — ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter
- K190473 — ACIST RXi System and Navvus II Catheter
Adverse events under product code DXT
product code DXT- Death
- 39
- Injury
- 242
- Malfunction
- 463
- Other
- 3
- Total
- 747
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.