IG4 IMAGE GUIDED SYSTEM— 510(k) K060903
Substantially EquivalentVeran Medical Technologies, Inc.
FDA 510(k) clearance K060903 for IG4 IMAGE GUIDED SYSTEM, Substantially Equivalent on 2006-05-11. Applicant: Veran Medical Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- Veran Medical Technologies, Inc.
- Product code
- Code JAK
- Device class
- Class 2
- Regulation
- 21 CFR 892.1750
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Nashville, TN, US
Recent devices under product code JAK
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- K093995 — IG 4 IMAGE GUIDED SYSTEM
- K091934 — IG4 ENDOBRONCHIAL, MODEL SYS-0200, NAVIGATION GUIDEWIRE (ACCESSORY TO IG4 ENDOBRONCHIAL), MODEL INS-0300
Adverse events under product code JAK
product code JAK- Death
- 27
- Injury
- 571
- Malfunction
- 779
- Total
- 1,377
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.