Monaco RTP System— 510(k) K183037
Substantially EquivalentElekta, Inc.
FDA 510(k) clearance K183037 for Monaco RTP System, Substantially Equivalent on 2018-12-04. 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 K183037
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-1825-2020 — Elekta MONACO RTP Sytem, radiation treatment planning software system - Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The
- Z-0670-2020 — Monaco Radiation Treatment Planning System (RTP) System
- Z-2560-2019 — Monaco RTP System, 5.40 Unity, 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-0965-2019 — Monaco Radiation Treatment Planning (RTP) System
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K183037.
Data sourced from openFDA. This site is unofficial and independent of the FDA.