Atlas FDA

GE SIGNA EXCITE MR SURGICAL OPTION

FDA 510(k) clearance K043262 · decided 2005-01-12

Clearance details

K-number
K043262
Device name
GE SIGNA EXCITE MR SURGICAL OPTION
Applicant
GE Healthcare
Decision
Substantially Equivalent
Date received
2004-11-24
Decision date
2005-01-12
Days to decision
49 days
Clearance type
Traditional
Product code
LNH
Device class
2
Regulation number
892.1000
Medical specialty
Radiology
Advisory committee
Radiology
Location
Milwaukee, WI, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
MR Surgical Suite II Table, Model Number(s): M8074SS, M8053SS, M0074SS. UPDATE 11-4-2015: recall (Z-0196-2016)GE Medical Systems, LLC2015-10-30
GE SIGNA EXCITE MR SURGICAL OPTION (MR450w Surgical Suite). The MR Surgical Option when in recall (Z-1067-2012)GE Healthcare, LLC2012-02-21

PMA approvals by this applicant

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Invenia ABUS Premium, Invenia ABUS Prime (P110006/S011)GE Healthcare2025-02-04
Senographe Pristina 3D and SenoClaire (P130020/S004)GE Healthcare2021-03-23
Invenia ABUS (Automated Breast Ultrasound System) 2.0 (P110006/S010)GE Healthcare2018-08-24
Invenia ABUS 2.0 Automated Breast Ultrasound System (P110006/S009)GE Healthcare2018-05-11
Senographe Pristina 3D (P130020/S003)GE Healthcare2017-12-28
Invenia ABUS Autoated Breast Ultrasound System (P110006/S008)GE Healthcare2017-09-07
Invenia ABUS - Automated Breast Ultrasound System (P110006/S007)GE Healthcare2017-05-01