MONACO— 510(k) K132971
Substantially EquivalentImpac Medical Systems, Inc.
FDA 510(k) clearance K132971 for MONACO, Substantially Equivalent on 2013-11-20. Applicant: Impac Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Impac Medical Systems, Inc.
- Product code
- Code MUJ
- Device class
- Class 2
- Regulation
- 21 CFR 892.5050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Maryland Heights, MO, US
Recent devices under product code MUJ
view allMore clearances from Impac Medical Systems, Inc.
view allRecalls naming K132971
K-number listed on FDA's recall record- Z-1009-2017 — Monaco RTP System Product Usage: Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
- Z-0668-2017 — Monaco TRP System The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy.
- Z-1237-2015 — Monaco radiation therapy treatment planning system. The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon and electron treatment plans and displays, on-screen and in hard-copy, two or three-dimensional radiation dose distributions inside patients for given treatment plan set-ups.
- Z-2581-2014 — Monaco The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon and electron treatment plans and displays, on-screen and in hard-copy, two or three-dimensional radiation dose distributions inside patients for given treatment plan set-ups.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K132971.
Data sourced from openFDA. This site is unofficial and independent of the FDA.