Company ยท US
Computerized Medical Systems Inc
FDA 510(k) clearances and medical device recalls filed under this name, 1985 to 2011. Name variants (Inc, Corp, punctuation) are merged.
23510(k) clearances (0 in 12 months)
32recalls (0 in 12 months)
32recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MUJ | System, Planning, Radiation Therapy Treatment | 40 |
| IYE | Accelerator, Linear, Medical | 5 |
| KPQ | System, Simulation, Radiation Therapy | 3 |
| LHN | System, Radiation Therapy, Charged-Particle, Medical | 2 |
| DPS | Electrocardiograph | 1 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 1 |
| ITX | Transducer, Ultrasonic, Diagnostic | 1 |
| IXI | Block, Beam-Shaping, Radiation Therapy | 1 |
| JAD | System, Therapeutic, X-Ray | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 24, 2011 | K110730 | MONACO RTP SYSTEM Computerized Medical Systems, Inc. | MUJ |
| Oct 1, 2010 | K102216 | XIO RTP SYSTEM Computerized Medical Systems, Inc. | MUJ |
| Sep 24, 2009 | K092132 | XIO RTP SYSTEM Computerized Medical Systems, Inc. | MUJ |
| Jul 16, 2009 | K091179 | MONACO RTP SYSTEM, VMAT OPTION Computerized Medical Systems, Inc. | MUJ |
| Aug 7, 2008 | K080799 | ATLAS-BASED AUTOSEGMENTATION Computerized Medical Systems, Inc. | LHN |
| Oct 1, 2007 | K071938 | MONACO RTP SYSTEM Computerized Medical Systems, Inc. | MUJ |
| Dec 2, 2003 | K032762 | XIO RADIATION TREATMENT PLANNING SYSTEM Computerized Medical Systems, Inc. | IYE |
| Oct 2, 2003 | K032100 | I-BEAM Computerized Medical Systems, Inc. | IYE |
| Oct 8, 2002 | K020027 | FOCUS RADIATION TREATMENT PLANNING SYSTEM Computerized Medical Systems, Inc. | MUJ |
| Dec 5, 2001 | K013112 | FOCAL SIM Computerized Medical Systems, Inc. | MUJ |
| Oct 13, 2000 | K002147 | FOCUS Computerized Medical Systems, Inc. | MUJ |
| Apr 17, 2000 | K000137 | ENHANCED COMPENSATING FILTER Computerized Medical Systems, Inc. | IXI |
| Apr 2, 1999 | K981535 | FOCUS PILOT CONTOURING WORKSTATION Computerized Medical Systems, Inc. | IYE |
| Jun 1, 1998 | K973936 | FOCUS RTP SYSTEM Computerized Medical Systems, Inc. | IYE |
| Feb 16, 1995 | K915691 | FOCUS RTP Computerized Medical Systems, Inc. | MUJ |
| Nov 2, 1992 | K921108 | CMS RECORD AND VERIFY Computerized Medical Systems, Inc. | KPQ |
| Nov 22, 1991 | K913674 | RECORD AND VERIFY MEVATRON ADAPTER Computerized Medical Systems, Inc. | IYE |
| Oct 17, 1991 | K913017 | MODULEX RTP SYSTEM Computerized Medical Systems, Inc. | KPQ |
| Dec 21, 1988 | K882484 | CMS RECORD AND VERIFY SYSTEM Computerized Medical Systems, Inc. | JAD |
| Jan 6, 1987 | K863535 | LIFE-TRACE 18 SINGLE-TRACE CARDIAC MONITOR/RECORD. Computerized Medical Systems, Inc. | DPS |
| Nov 21, 1986 | K863534 | LIFE-WATCH MONITOR LT-8 Computerized Medical Systems, Inc. | DRT |
| Jan 10, 1986 | K854880 | RADIATION BEAM DATA ACQUISTIOIN SYSTEMS Computerized Medical Systems, Inc. | KPQ |
| Dec 5, 1985 | K853964 | COMPUTERIZED RADIATION TREATMENT PLANNING SYS Computerized Medical Systems, Inc. | LHN |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 22, 2012 | Computerized Medical Systems Inc XiO Radiation Treatment Planning System, Versions 4.30.00-4.64.00.
Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. Terminated |
MUJ | K102216 |
| Apr 3, 2012 | Computerized Medical Systems Inc Monaco Radiation Treatment Planning System, Version 3.10.00.
Planning of radiation therapy. Terminated |
MUJ | K110730 |
| Aug 3, 2011 | Computerized Medical Systems Inc XiO Radiation Treatment Planning System, XiO versions equal to or greater than 2.4.0 and less than 4.63.0
The XiO RTP System is used to create treatment plans for any cancer patient for whom external Terminated |
MUJ | K102216 |
| Jun 23, 2011 | Computerized Medical Systems Inc Interplant Radiation Treatment Planning System, Interplant Release 3.4.0
Used when planning and performing prostate brachytherapy implant procedure. It provides ultrasound probe alignment and radioac Terminated |
MUJ | K982696 |
| Jun 23, 2011 | Computerized Medical Systems Inc ERGO++ Stereotactic Radiation Treatment Planning System, ERGO++ Release 1.6.3 and 1.6.3.1
Product Usage: Used to create treatment plans for any cancer patient for who external beam radiation therapy Terminated |
MUJ | K080601 |
| Jun 20, 2011 | Computerized Medical Systems Inc XiO Radiation Treatment Planning System, XiO Release 4.50.00 and above Terminated |
MUJ | K092132 |
| Jun 20, 2011 | Computerized Medical Systems Inc Focal Radiation Treatment Planning System, Focal Release 4.50.00 and above
for use in radiation treatment planning using generally accepted contouring methods. The Focal software allows users to acc Terminated |
MUJ | K013112 |
| Jun 20, 2011 | Computerized Medical Systems Inc XiO Radiation Treatment Planning System, XiO Release 2.1.0 and above
Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed Terminated |
MUJ | K092132 |
| Jun 20, 2011 | Computerized Medical Systems Inc XiO Radiation Treatment Planning System, XiO Release 4.0.2 and above
Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed. Terminated |
MUJ | K092132 |
| Jun 20, 2011 | Computerized Medical Systems Inc Focal Radiation Treatment Planning System, Focal Release 4.3.0 through 4.34.01
For use in radiation treatment planning using generally accepted contouring methods. The Focal software allows users to Terminated |
MUJ | K013112 |
| Jun 20, 2011 | Computerized Medical Systems Inc Focal Radiation Treatment Planning System, Focal Release 4.40.00 and above.
Product Usage: for use in radiation treatment planning using generally accepted contouring methods. The Focal software a Terminated |
MUJ | K013112 |
| Jun 20, 2011 | Computerized Medical Systems Inc Focal Radiation Treatment Planning System, Focal Release 4.1.1 through 4.40.00.
Product Usage: for use in radiation treatment planning using generally accepted contouring methods. The Focal softwar Terminated |
MUJ | K013112 |
| Jun 20, 2011 | Computerized Medical Systems Inc Monaco Radiation Treatment Planning Workstation, Monaco Release 2.03.00 and above
To create treatment plans for any cancer patient for whom external beam intensity modulated radiation therapy (IMRT) h Terminated |
MUJ | K071938 K091179 |
| Jun 17, 2011 | Computerized Medical Systems Inc XiO Radiation Treatment Planning System. XiO Release 4.50.00 and above
Used to create treatment plans for any cancer patient for who external beam radiation therapy of brachytherapy has been prescrib Terminated |
MUJ | K102216 |
| Jun 16, 2011 | Computerized Medical Systems Inc XiO Radiation Treatment Planning System, XiO Release 4.0.0 through 4.40.00
Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been pres Terminated |
MUJ | K092132 |
| Jun 16, 2011 | Computerized Medical Systems Inc XiO Radiation treatment Planning System, XiO Release 4.2.0 and above
Usage: Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been pre Terminated |
MUJ | K092163 |
| Jun 16, 2011 | Computerized Medical Systems Inc XiO Radiation Treatment Planning System, XiO Release 4.3.0 and above
Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribed Terminated |
MUJ | K092132 |
| Jun 15, 2011 | Computerized Medical Systems Inc Focal Radiation Treatment Planning System, Focal Release 4.3.1 through 4.34.02.
For use in radiation treatment planning using generally accepted contouring methods. The Focal software allows users Terminated |
MUJ | K013112 |
| Jun 15, 2011 | Computerized Medical Systems Inc XiO Radiation Treatment Planning System, XiO Release 4.3.1 through 4.40.00.
Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been pr Terminated |
MUJ | K092132 |
| Jun 15, 2011 | Computerized Medical Systems Inc XiO Radiation Treatment Planning System, XiO Release 4.3.0 through 4.50.00.
Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been pre Terminated |
MUJ | K092132 |
| Jun 15, 2011 | Computerized Medical Systems Inc XiO Radiation Treatment Planning System, XiO Release 1.5.0 and above.
Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribe Terminated |
MUJ | K092132 |
| Jun 15, 2011 | Computerized Medical Systems Inc Monaco Radiation Treatment Planning Workstation. Monaco Release 2.04.00 and above.
Used to create treatment plans for any cancer patient for who external beam intensity modulated radiation therapy ( Terminated |
MUJ | K071938 K091179 |
| Jun 14, 2011 | Computerized Medical Systems Inc Monaco Radiation Treatment Planning System, Monaco Release 2.0.1 and above
Used to create treatment plans for any cancer patient for who external beam intensity modulated radiation therapy (IMRT) has Terminated |
MUJ | K071938 K091179 |
| Jun 14, 2011 | Computerized Medical Systems Inc Monaco Radiation Treatment Planning System, Monaco Release 1.0.0 through 1.0.2.
Used to create treatment plans for any cancer patient for who external beam intensity modulated radiation therapy (IMR Terminated |
MUJ | K071938 K091179 |
| Jun 14, 2011 | Computerized Medical Systems Inc Focal Radiation Treatment Planning System, Focal Release 4.34.00 through 4.50.00.
For use in radiation treatment planning using generally accepted contouring methods. The Focal software allows users Terminated |
MUJ | K013112 |
| Jun 14, 2011 | Computerized Medical Systems Inc Focal Radiation Treatment Planning Workstation. Focal Release 4.51.00 and above.
Allows users to access XiO and other RTP systems from a remote PC-based system and provides the user with the ability t Terminated |
MUJ | K013112 |
| Jun 14, 2011 | Computerized Medical Systems Inc Monaco Radiation Treatment Planning Workstation. Monaco Release 2.03.00 and above.
The Monaco RTP system is used to create treatment plans for any cancer patient for whom external beam intensity mo Terminated |
MUJ | K071938 K091179 |
| Jun 3, 2011 | Computerized Medical Systems Inc XiO Radiation Treatment Planning System, XiO Release 1.0.2 and above.
Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescribe Terminated |
MUJ | K092132 |
| Jun 2, 2011 | Computerized Medical Systems Inc XiO Radiation Treatment Planning System, XiO Release 4.50.00 and above
Used to create treatment plans for any cancer patient for who external beam radiation therapy or brachytherapy has been prescrib Terminated |
MUJ | K092132 |
| May 26, 2010 | Computerized Medical Systems Inc Elekta XiO Radiation Treatment Planning System Terminated |
MUJ | K092132 |
| Mar 25, 2010 | Computerized Medical Systems Inc XiO Radiation Treatment Planning System, Release 4.51.00. Terminated |
MUJ | K092132 |
| Nov 29, 2006 | Computerized Medical Systems Inc AccuSeed DS Digital Stepper, an accessory to a prostate radiation treatment planning system. Model #DS300 Terminated |
ITX | K963302 |