ACUNAV Luxera 4D ICE Catheter— 510(k) K261696
Substantially EquivalentSiemens Medical Solutions USA, Inc.
FDA 510(k) clearance K261696 for ACUNAV Luxera 4D ICE Catheter, Substantially Equivalent on 2026-09-10. Applicant: Siemens Medical Solutions USA, Inc.. Device class: 2.
Summary
The ACUNAV Luxera 4D ICE Catheter is an intracardiac echocardiography catheter from Siemens Healthineers' AcuNav line. ICE catheters image the heart from inside the chambers during ablation and structural heart procedures, and "4D" means real-time volumetric imaging. It's filed under OBJ, intravascular ultrasound catheters.
Class II, 21 CFR 870.1200, Cardiovascular panel. It's a Special 510(k), so Siemens was modifying a catheter it already had cleared.
Siemens Medical Solutions USA filed from Issaquah, Washington, where its ultrasound business is based. Review took 111 days (May 22 to September 10, 2026), long for a Special.
Clearance details
- Applicant
- Siemens Medical Solutions USA, Inc.
- Product code
- Code OBJ
- Device class
- Class 2
- Regulation
- 21 CFR 870.1200
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Issaquah, WA, US
Recent devices under product code OBJ
view allMore clearances from Siemens Medical Solutions USA, Inc.
view allAdverse events under product code OBJ
product code OBJ- Death
- 38
- Injury
- 634
- Malfunction
- 3,453
- Total
- 4,125
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.