Monaco— 510(k) K151233
Substantially EquivalentImpac Medical Systems, Inc.
FDA 510(k) clearance K151233 for Monaco, Substantially Equivalent on 2015-07-07. 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 K151233
K-number listed on FDA's recall record- Z-1233-2023 — Monaco RTP System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
- Z-2091-2019 — Monaco RTP System, software versions 5.10 and 5.11, Radiation Treatment Planning System
- Z-1044-2017 — Monaco RTP System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
- Z-1009-2017 — Monaco RTP System Product Usage: Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
- Z-0660-2017 — Monaco RTP System; Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
- Z-0076-2017 — Monaco RTP 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 treatment plans and displays, on-screen and in hard-copy, two or three dimensional radiation dose distribution inside patients for given treatment plan set-ups
- Z-1879-2016 — Monaco RTP System Product Usage: The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy.
- Z-0181-2016 — Monaco - Radiation Treatment Planning used to make treatment plans for patients with prescriptions for external beam radiation therapy.
- Z-0112-2016 — Monaco Radiation Treatment Planning System. Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K151233.
Data sourced from openFDA. This site is unofficial and independent of the FDA.