ONEDOSE PATIENT DOSIMETRY SYSTEM— 510(k) K040687
Substantially EquivalentSicel Technologies, Inc.
FDA 510(k) clearance K040687 for ONEDOSE PATIENT DOSIMETRY SYSTEM, Substantially Equivalent on 2004-06-25. Applicant: Sicel Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- Sicel Technologies, Inc.
- Product code
- Code IYE
- Device class
- Class 2
- Regulation
- 21 CFR 892.5050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Morrisville, NC, US
Recent devices under product code IYE
view allMore clearances from Sicel Technologies, Inc.
view all- K083035 — DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM
- K081859 — MODIFICATION TO ONEDOSE PATIENT DOSIMETRY SYSTEM
- K080004 — DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM
- K071399 — DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODEL DVS-I-11: DVS INSERTION TOOL, DVS-D-A: DVS DOSIMETER, DVS-R-100
- K061051 — DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODELS DVS-I-11, DVS INSERTION TOOL, DVS-D-A, DVS DOSIMETER
Adverse events under product code IYE
product code IYE- Malfunction
- 455
- Other
- 3
- Total
- 458
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.