Atlas FDA

PRIMUS

FDA 510(k) clearance K993425 · decided 1999-11-26

Clearance details

K-number
K993425
Device name
PRIMUS
Applicant
Siemens Medical Solutions USA, Inc.
Decision
Substantially Equivalent
Date received
1999-10-12
Decision date
1999-11-26
Days to decision
45 days
Clearance type
Special
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

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Recalls involving this device

RecordFirmDate
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
LINAC Accelerators: ARTISTE, ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, O recall (Z-1059-2015)Siemens Medical Solutions USA, Inc2015-02-05
Siemens Linear Accelerator: ARTISTE, ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expre recall (Z-0980-2015)Siemens Medical Solutions USA, Inc2015-01-15
PRIMUS, ONCOR, ARTISTE Linac systems with component Tabletop, 550TxT, TT-A s/n 1001-1233 a recall (Z-2095-2013)Siemens Medical Solutions USA, Inc2013-08-26
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
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
PRIMUS HI; Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and MEVATRON Linear recall (Z-0782-2012)Siemens Medical Solutions USA, Inc2012-01-17
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
MEV ATRON M2/PRIMUS MID-ENERGY, camera imaging system, Part Number: 1940035; Product is ma recall (Z-2640-2011)Siemens Medical Solutions USA, Inc - Radiation Oncology2011-06-23
PRIMUS HI, camera imaging system, Part Number: 4504200; Product is manufactured and distri recall (Z-2641-2011)Siemens Medical Solutions USA, Inc - Radiation Oncology2011-06-23
ONCOR Impression, camera imaging system, Part Number: 5857920; Product is manufactured and recall (Z-2643-2011)Siemens Medical Solutions USA, Inc - Radiation Oncology2011-06-23
ONCOR Impression Plus, camera imaging system, Part Number: 5857912, Product is manufacture recall (Z-2644-2011)Siemens Medical Solutions USA, Inc - Radiation Oncology2011-06-23
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
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
Siemens Medical Solutions, PRIMUS Plus Digital Linear Accelerator, part number 4504200 equ recall (Z-1759-2008)Siemens Medical Solutions USA, Inc2008-09-29
Primus Plus Medical Linear Accelerator, Material Number : 4504200, with control console so recall (Z-1396-2008)Siemens Medical Solutions USA, Inc2008-04-02
Oncor Impression Plus Medical Linear Accelerator, Material Number : 5857912, with control recall (Z-1397-2008)Siemens Medical Solutions USA, Inc2008-04-02
Oncor Impression Medical Linear Accelerator, Material Number : 5857920, with control conso recall (Z-1398-2008)Siemens Medical Solutions USA, Inc2008-04-02
Siemens Primus Linear Accelerator System, PRIMART MX Linear Accelerator System; PRIMUS Mid recall (Z-0850-2008)Siemens Medical Solutions USA, Inc2008-02-19
Siemens Mevatron M-2 PRIMUS mid-energy Medical Charged-Particle Radiation Therapy System; recall (Z-0686-2008)Siemens Medical Solutions USA, Inc2008-02-14
Siemens Mevatron M-2 PRIMUS hi-energy Medical Charged-Particle Radiation Therapy System; ( recall (Z-0687-2008)Siemens Medical Solutions USA, Inc2008-02-14
Siemens, Mevatron M2/PRIMUS Plus, Part No.: 45 04 200, High EnergyMedical Charge particle recall (Z-0380-2008)Siemens Medical Solutions USA, Inc2007-12-01
ONCOR IMPRESSION Plus,Medical charge-particle radiation therapy system (Medical Digital Li recall (Z-0166-2008)Siemens Medical Solutions USA, Inc2007-11-09
ONCOR IMPRESSION,Medical charge-particle radiation therapy system (Medical Digital Linear recall (Z-0167-2008)Siemens Medical Solutions USA, Inc2007-11-09
MEVATRON M2/PRIMUS Mid,Medical charge-particle radiation therapy system (Medical Digital L recall (Z-0168-2008)Siemens Medical Solutions USA, Inc2007-11-09
PRIMUS Plus,Medical charge-particle radiation therapy system (Medical Digital Linear Accel recall (Z-0169-2008)Siemens Medical Solutions USA, Inc2007-11-09
Siemens brand PRIMUS Linear Accelerators equipped with the optional Retractable Beam Shiel recall (Z-0355-06)Siemens Medical Solutions USA, Inc2006-01-06

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