AEGIS— 510(k) K070244
Substantially EquivalentSentinelle Medical, Inc.
FDA 510(k) clearance K070244 for AEGIS, Substantially Equivalent on 2007-02-09. Applicant: Sentinelle Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Sentinelle Medical, 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
- Toronto, Ontario, CA
Recent devices under product code LLZ
view allMore clearances from Sentinelle Medical, Inc.
view all- K103274 — SENTINELLE ENDO COIL ARRAY FOR PELVIC IMAGING
- K100113 — VANGUARD BREAST MRI AUXILIARY TABLE WITH 16 CHANNEL COIL ARRAY FOR GE 3T MRI SYSTEM, MODEL 4000451-51
- K093672 — AEGIS NAVIGATION ANDA EGIS PELVIC APPLICATION
- K060873 — VANGUARD MRI AUXILIARY PATIENT TABLE WITH 4 AND 8 CHANNEL COIL ARRAY FOR GE SIGNA SYSTEMS
Adverse 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.