DEXTROSCOPE & DEXTROBEAM— 510(k) K053162
Substantially EquivalentVolume Interactions Pte, Ltd.
FDA 510(k) clearance K053162 for DEXTROSCOPE & DEXTROBEAM, Substantially Equivalent on 2005-12-09. Applicant: Volume Interactions Pte, Ltd.. Device class: 2.
Clearance details
- Applicant
- Volume Interactions Pte, Ltd.
- 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
- Special
- Location
- Tower, Singapore, SG
Recent devices under product code LLZ
view allMore clearances from Volume Interactions Pte, Ltd.
view all- K071054 — RADIODEXTER, DEXTROSCOPE, DEXTROBEAM, MODELS 1.0, MK10, MK3 & MK4
- K063730 — DEXTROSCOPE, MODEL MK10; DEXTROBEAM, MODEL MK3, MK4; RADIODEXTER, MODEL 1.0
- K032924 — RADIODEXTER VERSION 1.0, DEXTROSCOPE, MODEL MK10 AND DEXTROBEAM, MODEL MK3
- K022938 — VIZDEXTER VERSION 2.0; DEXTROSCOPE MK8; DEXTROBEAM MK3
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.