INTELEPACS, MODEL VERSION 3.X.X— 510(k) K083520
Substantially EquivalentIntelerad Medical Systems Incorporated
FDA 510(k) clearance K083520 for INTELEPACS, MODEL VERSION 3.X.X, Substantially Equivalent on 2009-06-23. Applicant: Intelerad Medical Systems Incorporated. Device class: 2.
Clearance details
- Applicant
- Intelerad Medical Systems Incorporated
- 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
- Montreal, Qb, CA
Recent devices under product code LLZ
view allMore clearances from Intelerad Medical Systems Incorporated
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 →
Recalls naming K083520
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K083520.
Data sourced from openFDA. This site is unofficial and independent of the FDA.