Monaco RTP System— 510(k) K190178
Substantially EquivalentElekta, Inc.
FDA 510(k) clearance K190178 for Monaco RTP System, Substantially Equivalent on 2019-03-29. Applicant: Elekta, Inc.. Device class: 2.
Clearance details
- Applicant
- Elekta, 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 Elekta, Inc.
view allRecalls naming K190178
K-number listed on FDA's recall record- Z-2563-2021 — Elekta Monaco - Product Usage: used to make treatment plans for patients with prescriptions for external beam radiation therapy.
- Z-2406-2021 — Monaco RTP System, Software Builds 5.40.00, 5.40.01, 5.40.02, and 5.51.10
- Z-0670-2020 — Monaco Radiation Treatment Planning System (RTP) System
- Z-2561-2019 — Monaco RTP System, 5.50/5.51, radiation treatment planning system Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon, electron, and carbon 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. The Monaco product line is intended for use in radiation treatment planning. It uses generally accepted methods for: -contouring -image manipulation -simulation -image fusion -plan optimization -QA and plan review
- Z-2409-2019 — Monaco Radiation Treatment Planning System (RTP) System
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K190178.
Data sourced from openFDA. This site is unofficial and independent of the FDA.