XIO RTP SYSTEM— 510(k) K102216
Substantially EquivalentComputerized Medical Systems, Inc.
FDA 510(k) clearance K102216 for XIO RTP SYSTEM, Substantially Equivalent on 2010-10-01. 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 K102216
K-number listed on FDA's recall record- Z-0130-2016 — XiO Radiation Treatment Planning System. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed.
- Z-1197-2014 — XiO RPT System The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. The system will calculate and display, both on screen and in hard-copy, either two or three dimensional radiation dose distributions within a patient for a given treatment.
- Z-0780-2014 — XiO RTP System The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. The system will calculate and display, both on-screen and in hard-copy, either two or three-dimensional radiation dose distributions within a patient for a given treatment plan set-up.
- Z-0928-2014 — XiO RTP System. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K102216.
Data sourced from openFDA. This site is unofficial and independent of the FDA.