MONACO RTP SYSTEM— 510(k) K110730
Substantially EquivalentComputerized Medical Systems, Inc.
FDA 510(k) clearance K110730 for MONACO RTP SYSTEM, Substantially Equivalent on 2011-06-24. Applicant: Computerized Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Computerized 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 Computerized Medical Systems, Inc.
view allRecalls naming K110730
K-number listed on FDA's recall record- Z-2712-2016 — Monaco RTP System Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
- Z-2276-2013 — Monaco RTP System Radiation treatment planning
- Z-2277-2013 — Monaco RTP System Radiation Therapy Treatment Planning System. Radiation treatment planning.
- Z-0841-2013 — Monaco RTP System. Radiation treatment planning.
- Z-2007-2012 — Monaco Product Usage: Planning of radiation therapy
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K110730.
Data sourced from openFDA. This site is unofficial and independent of the FDA.