PROTOS SOFTWARE— 510(k) K040709
Substantially EquivalentAktina Medical Physics Corp.
FDA 510(k) clearance K040709 for PROTOS SOFTWARE, Substantially Equivalent on 2004-04-28. Applicant: Aktina Medical Physics Corp.. Device class: 2.
Clearance details
- Applicant
- Aktina Medical Physics Corp.
- 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
- Congers, NY, US
Recent devices under product code IYE
view allMore clearances from Aktina Medical Physics Corp.
view all- K103616 — PINPOINT STEREOTACTIC HEAD AND NECK LOCALIZER
- K081935 — STEREOTACTIC HEAD AND NECK LOCALIZER, MODEL 50-100
- K032248 — PRECISE CARBON FIBER TABLE TOP, MODEL 11-999
- K014081 — AKTINA MEDICAL PHYSICS RADIATION THERAPY WEDGES
- K003330 — AKTINA MEDICAL PHYSICS CORPORATION ACTIVE BREATHING COORDINATOR (ABC)
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.