Atlas FDA

ONCOR EXPRESSION

FDA 510(k) clearance K060226 · decided 2006-03-15

Clearance details

K-number
K060226
Device name
ONCOR EXPRESSION
Applicant
Siemens Medical Solutions USA, Inc.
Decision
Substantially Equivalent
Date received
2006-01-30
Decision date
2006-03-15
Days to decision
44 days
Clearance type
Traditional
Product code
IYE
Device class
2
Regulation number
892.5050
Medical specialty
Radiology
Advisory committee
Radiology
Location
Concord, CA, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Siemens Medical Solutions USA

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Halcyon, Ethos Radiotherapy System (5.0) (K261856)Varian Medical Systems, Inc.2026-08-03
ThinkQA 3 (K252937)Dosisoft SA2026-06-12
LUNA 3D (K253004)Lap GmbH Laser Applikationen2026-06-04
AerFrame Patient Immobilization System (AFPIS) (K260792)Stabilix, LLC2026-05-08
VERIQA RT EPID 3D (K252258)Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla2026-04-15
ClearCheck (RADCC V2.7) (K253962)Radformation, Inc.2026-04-03
AlignRT Plus (8.0) (K253012)Vision Rt, Ltd.2026-03-18
Halcyon, Ethos Radiotherapy System (5.0) (K252977)Varian Medical Systems, Inc.2026-01-21
EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy) (K252188)Elekta Solutions AB2026-01-15
ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface (K254010)Brainlab SE2026-01-14
ChartCheck (RADCH V1.6) (K252988)Radformation, Inc.2026-01-05
IDENTIFY (5.0) (K252919)Varian Medical Systems, Inc.2025-12-16

Recalls involving this device

RecordFirmDate
Lantis system (pre-2003), Model #5835991 - Product Usage: Lantis Treatstation is to allow recall (Z-2198-2019)Siemens Medical Solutions USA, Inc2019-08-06
ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIMUS HI, M recall (Z-0168-2016)Siemens Medical Solutions USA, Inc2015-10-27
ARTISTE, ONCOR Avantgarde, ONCOR Impression Plus, ONCOR Expression, PRIMUS, PRIMUS Plus, S recall (Z-2812-2015)Siemens Medical Solutions USA, Inc2015-09-24
ARTISTE MV System, Linear Accelerator (LINAC) with SysVC10A software. The intended use of recall (Z-0984-2015)Siemens Medical Solutions USA, Inc2015-03-18
LINAC Accelerators: ARTISTE, ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, O recall (Z-1059-2015)Siemens Medical Solutions USA, Inc2015-02-05
SIEMENS brand ONCOR series Linear Accelerator Linac systems with component: any photon unf recall (Z-0437-2014)Siemens Medical Solutions USA, Inc2013-12-03
Siemens MEVATRON series, PRIMART (limited release)PRIMUS and/or ONCOR or ARTIST Linac Syst recall (Z-1663-2013)Siemens Medical Solutions USA, Inc2013-07-03
Software correction applies to customers who use the RT Therapist RTT4.2.108 and RT Therap recall (Z-1182-2013)Siemens Medical Solutions USA, Inc2013-04-26
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; S recall (Z-1036-2013)Siemens Medical Solutions USA, Inc2013-04-02
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; S recall (Z-1037-2013)Siemens Medical Solutions USA, Inc2013-04-02
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; S recall (Z-1038-2013)Siemens Medical Solutions USA, Inc2013-04-02
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; S recall (Z-1039-2013)Siemens Medical Solutions USA, Inc2013-04-02
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; S recall (Z-1040-2013)Siemens Medical Solutions USA, Inc2013-04-02
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; S recall (Z-1041-2013)Siemens Medical Solutions USA, Inc2013-04-02
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; S recall (Z-1042-2013)Siemens Medical Solutions USA, Inc2013-04-02
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; S recall (Z-1043-2013)Siemens Medical Solutions USA, Inc2013-04-02
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; S recall (Z-1044-2013)Siemens Medical Solutions USA, Inc2013-04-02
Siemens-branded ONCOR" or PRIMUS" linear accelerator with an OPTIVUE" or MVision" imaging recall (Z-1494-2012)Siemens Medical Solutions USA, Inc2012-05-08
Siemens-branded linear accelerator with a 550 TxT Treatment Table with a serial number <_ recall (Z-1486-2012)Siemens Medical Solutions USA, Inc2012-05-03
ARTISTE, ONCOR and PRIMUS Linear Accelerators with RT Therapist Workspace, version 4.1. Ma recall (Z-1092-2012)Siemens Medical Solutions USA, Inc2012-02-23
ARTISTE and ONCOR linear accelerators with G31 mother board. ARTISTE and ONCOR are manufac recall (Z-0459-2012)Siemens Medical Solutions USA, Inc2012-01-11
ARTISTE Linear Accelerator with RT Therapist v4.1 system. Siemens Medical Solutions, Kemna recall (Z-3003-2011)Siemens Medical Solutions USA, Inc2011-08-11
ONCOR/PRIMUS Linear Accelerator systems with RTT v2.x AND an ARTISTE Linear Accelerator/RT recall (Z-2789-2011)Siemens Medical Solutions USA, Inc2011-07-11
ARTISTE , ONCOR and PRIMUS digital accelerators with syngo RT Therapist v4.1 and 4.2 syste recall (Z-2243-2011)Siemens Medical Solutions USA, Inc2011-05-23
ARTISTE , ONCOR and PRIMUS accelerators that utilize the RT Therapist v4.2 system in combi recall (Z-2216-2011)Siemens Medical Solutions USA, Inc2011-05-19
ARTISTE / RT Therapist v4.1 system. The ONCOR and PRIMUS system may be updated to utilize recall (Z-2190-2011)Siemens Medical Solutions USA, Inc2011-05-12
Siemens LANTIS 6.1 Oncology Information System with MEDOne Module, Linear Medical Accelera recall (Z-2000-2011)Siemens Medical Solutions USA, Inc2011-04-15
LANTIS oncology Information System, an accessory to the Linear Accelerator, as part of the recall (Z-1970-2011)Siemens Medical Solutions USA, Inc2011-04-13
Coherence AG Therapist Part number 5863506, equipped with a Coherence Therapist R2.0 or R2 recall (Z-0089-2009)Siemens Medical Solutions USA, Inc2008-10-16
Coherence Therapist System Part number 7339125 Medical charged-particle radiation therapy recall (Z-0090-2009)Siemens Medical Solutions USA, Inc2008-10-16
Coherence Impression Therapist System equipped with a Coherence Therapist R2.0 or R2.1, an recall (Z-0091-2009)Siemens Medical Solutions USA, Inc2008-10-16
PRIMEVIEW 3i System equipped with a Coherence Therapist R2.0 or R2.1, and PRIMEVIEW 3iR2.0 recall (Z-0092-2009)Siemens Medical Solutions USA, Inc2008-10-16
AG Therapist 3rd party V&R equipped with a Coherence Therapist R2.0 or R2.1, and PRIMEVIEW recall (Z-0093-2009)Siemens Medical Solutions USA, Inc2008-10-16
Impression Therapist 3rd party V&R equipped with a Coherence Therapist R2.0 or R2.1, and P recall (Z-0094-2009)Siemens Medical Solutions USA, Inc2008-10-16
Syngo Based WS for 3rd party equipped with a Coherence Therapist R2.0 or R2.1, and PRIMEVI recall (Z-0095-2009)Siemens Medical Solutions USA, Inc2008-10-16
Coherence Therapist 2.0 equipped with a Coherence Therapist R2.0 or R2.1, and PRIMEVIEW 3i recall (Z-0096-2009)Siemens Medical Solutions USA, Inc2008-10-16
PRIMEVIEW 3i System 2.0 equipped with a Coherence Therapist R2.0 or R2.1, and PRIMEVIEW 3i recall (Z-0097-2009)Siemens Medical Solutions USA, Inc2008-10-16
Coherence Therapist System 2.1 equipped with a Coherence Therapist R2.0 or R2.1, and PRIME recall (Z-0098-2009)Siemens Medical Solutions USA, Inc2008-10-16
PRIMEVIEW 3i System 2.1 equipped with a Coherence Therapist R2.0 or R2.1, and PRIMEVIEW 3i recall (Z-0099-2009)Siemens Medical Solutions USA, Inc2008-10-16
Siemens Medical Solutions, ONCOR IMPRESSION Plus Digital Linear Accelerator, part number 5 recall (Z-1760-2008)Siemens Medical Solutions USA, Inc2008-09-29
Siemens Medical Solutions, MEVATRON M2-6740 part number 9401407equipped with a Digital Ele recall (Z-1761-2008)Siemens Medical Solutions USA, Inc2008-09-29
Siemens Medical Solutions, MEVATRON M2-6740 part number 9401506 equipped with a Digital El recall (Z-1762-2008)Siemens Medical Solutions USA, Inc2008-09-29
Siemens Medical Solutions, MEVATRON MD-2 part number 9401654 equipped with a Digital Elect recall (Z-1763-2008)Siemens Medical Solutions USA, Inc2008-09-29
Radiation therapy system - Coherence AG Therapist Part number 5863506 and Therapist system recall (Z-2095-2008)Siemens Medical Solutions USA, Inc2008-09-17
Radiation therapy system - Coherence Impression Therapist System equipped with a Coherence recall (Z-2096-2008)Siemens Medical Solutions USA, Inc2008-09-17
Radiation therapy system - PRIMEVIEW 3i System equipped with a Coherence Therapist RTT2.1 recall (Z-2097-2008)Siemens Medical Solutions USA, Inc2008-09-17
Radiation therapy system - AG Therapist 3rd party V&R equipped with Coherence Therapist RT recall (Z-2098-2008)Siemens Medical Solutions USA, Inc2008-09-17
Radiation therapy system - Impression Therapist 3rd party V&R equipped with Coherence Ther recall (Z-2099-2008)Siemens Medical Solutions USA, Inc2008-09-17
Radiation therapy system - Syngo Based WS for 3rd party V&R equipped with Coherence Therap recall (Z-2100-2008)Siemens Medical Solutions USA, Inc2008-09-17
Radiation therapy system - Coherence Therapist 2.0 equipped with Coherence Therapist RTT2. recall (Z-2101-2008)Siemens Medical Solutions USA, Inc2008-09-17

PMA approvals by this applicant

RecordFirmDate
MAMMOMAT B.brilliant with Tomosynthesis Option (P140011/S008)Siemens Medical Solutions USA, Inc.2024-09-23
MAMMOMAT Revelation with Tomosynthesis Option System (P140011/S007)Siemens Medical Solutions USA, Inc.2020-08-21
MAMMOMAT Revelation with Tomosynthesis Option (P140011/S006)Siemens Medical Solutions USA, Inc.2019-12-10
Mammomat Inspiration with Tomosynthesis Option / Mammomat Revelation with Tomosynthesis Option (P140011/S005)Siemens Medical Solutions USA, Inc.2017-09-29
MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION (P140011/S003)Siemens Medical Solutions USA, Inc.2017-03-23
MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION (P140011/S001)Siemens Medical Solutions USA, Inc.2016-05-12
MAMMOMAT INSPIRATION TOMOSYNTHESIS OPTION (P140011/S002)Siemens Medical Solutions USA, Inc.2016-01-13
MAMMOMAT INSPIRATION WITH TOMOSYNTHESIS OPTION (P140011)Siemens Medical Solutions USA, Inc.2015-04-21