# Acist Medical Systems, Inc.

- Location (FDA's records): Eden Prairie, MN
- FDA decisions: 24 (1999–2026): 24 510(k) clearances
- Names in FDA's records: Acist Medical Systems, Inc. (16); Acist Medical Systems (7); ACIST Medical Systems, Inc. (1)
- Product codes: DXT (12), OBJ (3), DXO (2), DQO (2), IZQ (2), DSA (1), OBI (1), DRQ (1)
- 510(k) review time since 2016: median 123 days, against 135 for FDA's reviews in the same codes and years (4 of 7 faster)
- Predicates its devices cite: 21 (11 its own); citations of its devices by later devices: 17 (11 its own)
- Recalls linked to its devices: 8 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Invasatec: 4 (https://510kreport.com/company/invasatec)
- Silicon Vally Medical Instruments, Inc.: 2 (https://510kreport.com/company/silicon-vally-medical-instruments)
- Radi Medical Systems AB: 1 (https://510kreport.com/company/radi-medical-systems)
- Volcano Corporation: 1 (https://510kreport.com/company/volcano)
- Merit Cables Incorporated: 1 (https://510kreport.com/company/merit-cables)
- E-Z-Em, Inc.: 1 (https://510kreport.com/company/e-z-em)

## Firms that cite its devices most
- Osprey Medical, Inc.: 4 (https://510kreport.com/company/osprey-medical)
- Endophys, Inc.: 2 (https://510kreport.com/company/endophys)

## Its most-cited devices
- K132474: Cardiovascular Pressure Measurement (CPM) System, Navvus Catheter (2014), cited by 3
- K991103: Modification to Acist CL 100H (2000), cited by 2
- K171646: ACISTCVi® Contrast Delivery System (2018), cited by 2
- K191175: ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System (2019), cited by 1
- K173063: ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System (2017), cited by 1
- K993774: Acist Angiographic Injection System, Model CL1OOH (1999), cited by 1

## Recent decisions
- K262115: VueJect® Ultrasound Enhancing Agent Delivery System (Aug 3, 2026)
- K252653: ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single Transducer Cable; Triple Transducer Cable (May 13, 2026)
- K252638: VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-Use Syringe (018811); VeraPro AMT Auto-Manifold and Transducer (018814); VeraPro AngioTouch FLX165 Hand Controller Kit (018806); VeraPro AngioTouch HiFi165 Hand Controller Kit (018804) (May 13, 2026)
- K233904: ACIST RXi System (016616); ACIST Navvus II Catheter (016675_ (Jul 17, 2024)
- K203004: ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System (Dec 17, 2020)
- K193183: ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter (Mar 20, 2020)
- K190473: ACIST RXi System and Navvus II Catheter (Sep 13, 2019)
- K191060: ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, AngioToiuch Hand Controller Kit (Jul 18, 2019)

Source page: https://510kreport.com/company/acist-medical-systems