ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single Transducer Cable; Triple Transducer Cable
FDA 510(k) clearance K252653 · decided 2026-05-13
Clearance details
- 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.
- Decision
- Substantially Equivalent
- Date received
- 2025-08-22
- Decision date
- 2026-05-13
- Days to decision
- 264 days
- Clearance type
- Traditional
- Product code
- DXT
- Device class
- 2
- Regulation number
- 870.1650
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Eden Prairie, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.