iNtuition-T1 Mapping and T2/T2* Mapping— 510(k) K180916
Substantially EquivalentTerarecon,Inc.
FDA 510(k) clearance K180916 for iNtuition-T1 Mapping and T2/T2* Mapping, Substantially Equivalent on 2018-09-24. Applicant: Terarecon,Inc.. Device class: 2.
Clearance details
- Applicant
- Terarecon,Inc.
- Product code
- Code LLZ
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Foster City, CA, US
Recent devices under product code LLZ
view allMore clearances from Terarecon,Inc.
view allAdverse events under product code LLZ
product code LLZ- Death
- 13
- Total
- 13
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.