Monaco RTP System
Elekta, Inc.
Elekta, Inc.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1937649 | 1937649 | Elekta, Inc. | 1 | N | 2020-04-25 | 1450 Beale Street, Suite 205 Saint Charles MO US 63303 |
| 2950347 | 1000123805 | Elekta, INC. | 1 | N | 2020-04-25 | 100 Mathilda Pl Fl 5 SUNNYVALE CA US 94086 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 91561 | 1811546542 | K981535 | FOCUS PILOT CONTOURING WORKSTATION | IYE | 1999-04-02 |
| 10752 | 1099994825 | K981313 | SEQUENCER | IYE | 1998-07-09 |
| 91561 | 1836692040 | K973936 | FOCUS RTP SYSTEM | IYE | 1998-06-01 |
| 91561 | 2070378980 | K915691 | FOCUS RTP | MUJ | 1995-02-16 |
| 91561 | 1293844943 | K190178 | Monaco RTP System | MUJ | 2019-03-29 |
| 91561 | 1129358406 | K183037 | Monaco RTP System | MUJ | 2018-12-04 |
| 10752 | 1550189801 | K183034 | MOSAIQ Oncology Information System | IYE | 2018-12-04 |
| 91561 | 1851715383 | K182855 | ProKnow DS | LLZ | 2019-01-02 |
| 91561 | 1024632609 | K151233 | Monaco | MUJ | 2015-07-07 |
| 10752 | 1814050539 | K141572 | MOSAIQ ONCOLOGY INFORMATION SYSTEM | IYE | 2014-09-05 |
| 91561 | 1397446106 | K132971 | MONACO | MUJ | 2013-11-20 |
| 10752 | 1495688786 | K123230 | MOSAIQ ONCOLOGY INFORMATION SYSTEM | IYE | 2012-12-12 |
| 10752 | 1845121494 | K120067 | MOSAIQ ONCOLOGY INFORMATION SYSTEM | IYE | 2012-02-28 |
| 91561 | 1729413360 | K110730 | MONACO RTP SYSTEM | MUJ | 2011-06-24 |
| 91561 | 1306159016 | K102216 | XIO RTP SYSTEM | MUJ | 2010-10-01 |
| 91561 | 1820762346 | K092132 | XIO RTP SYSTEM | MUJ | 2009-09-24 |
| 91561 | 1011560719 | K091179 | MONACO RTP SYSTEM, VMAT OPTION | MUJ | 2009-07-16 |
| 91561 | 1701719783 | K080799 | ATLAS-BASED AUTOSEGMENTATION | LHN | 2008-08-07 |
| 91561 | 1816788792 | K080601 | ERGO++ VERSION 1.7 | MUJ | 2008-06-06 |
| 91561 | 1939230671 | K071938 | MONACO RTP SYSTEM | MUJ | 2007-10-01 |
| 91561 | 1380929116 | K032762 | XIO RADIATION TREATMENT PLANNING SYSTEM | IYE | 2003-12-02 |
| 91561 | 1062126348 | K031281 | ERGO SRS | MUJ | 2003-12-23 |
| 91561 | 1144504338 | K020027 | FOCUS RADIATION TREATMENT PLANNING SYSTEM | MUJ | 2002-10-08 |
| 91561 | 1448690362 | K013112 | FOCAL SIM | MUJ | 2001-12-05 |
| 91561 | 1353966052 | K002147 | FOCUS | MUJ | 2000-10-13 |
| 10752 | 1001769738 | ||||
| 10752 | 1185301347 |