iNtuition-Structural Heart Module
510(k) K191585
iNtuition-Structural Heart Module is a Class II device made by Terarecon Inc., cleared under FDA 510(k) K191585 on 12 Jul 2019, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK191585 | Date12 Jul 2019 | StatusActive |
Official records
- FDA 510(k) database K191585
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LLZ
- FDA applicant
- Terarecon,Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K191585
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Intuition Intuition04 | Intuition / Intuition04 | INTUITION04 | — | On the market |
Similar devices
Other devices filed under FDA product code LLZ (System, Image Processing, Radiological).
- icobrain ctp 1 by icometrix NV
- ULTRASOUND WORKSTATION, UIWS-300A by Toshiba America Medical Systems, In.C
- SECTRA ANGIOGRAPHY PACKAGE AND SECTRA CARDIOLOGY PACKAGE by Sectra AB
- ImmersiveTouch3 and MicrovisTouch by ImmersiveTouch, Inc.
- Cyware 4H and Cysart 4H by Abys Medical
- QUANTUM/ CANON CXDI INTEGRATION SYSTEM, MODEL QG-DIG-CXDI by Quantum Medical Imaging, LLC
- Vitrea Software Package; VSTP-001A by Canon Medical Systems Corporation
- Hura CTP v1.0 by Hura Imaging, Inc.
- SYNAPSE 3D LIVER ANALYSIS by Fujifilm Medical System U.S.A., Inc.
- rTOP by Roclub GmbH