MEDRAD IMAGE MANAGEMENT SYSTEM (MIMS)— 510(k) K883604
Substantially EquivalentMedrad, Inc.
FDA 510(k) clearance K883604 for MEDRAD IMAGE MANAGEMENT SYSTEM (MIMS), Substantially Equivalent on 1988-11-15. Applicant: Medrad, Inc.. Device class: 2.
Clearance details
- Applicant
- Medrad, 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
- Indianola, PA, US
Recent devices under product code LLZ
view allMore clearances from Medrad, Inc.
view all- K133023 — JETSTREAM XC 2.4/3.4; JETSTREAM XC 2.1/3.0; JETSTREAM SC 1.85; JETSTREAM SC 1.6
- K130381 — ANGIOJET ULTRA POWER PULSE KIT
- K130637 — JETSTREAM XC 2.4/3.4 SYSTEM; JETSTREAM XC 2.1/3.0 SYSTEM; JETSTREAM SC 1.85 SYSTEM; JETSTREAM SC 1.6 SYSTEM
- K122916 — JETSTREAM NAVITUS L SYSTEM JEYSTREAM NAVITUS SYSTEM JETSTREAM G3 SF SYSTEM JETSTREAM SF 1.6 SYSTEM
- K113363 — ANGIOJET SOLENT DISTA THROMBECTOMY SET
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.