Atlas FDA

SIGNA Voyager

FDA 510(k) clearance K161567 · decided 2016-09-01

Clearance details

K-number
K161567
Device name
SIGNA Voyager
Applicant
GE Healthcare
Decision
Substantially Equivalent
Date received
2016-06-07
Decision date
2016-09-01
Days to decision
86 days
Clearance type
Traditional
Product code
LNH
Device class
2
Regulation number
892.1000
Medical specialty
Radiology
Advisory committee
Radiology
Location
Waukesha, WI, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
GE Signa Voyager, Nuclear Magnetic Resonance Imaging System recall (Z-2300-2025)GE Medical Systems, LLC2025-08-13
SIGNA Voyager nuclear magnetic resonance imaging system recall (Z-0138-2022)GE Healthcare, LLC2021-10-16
SIGNA Voyager, Nuclear Magnetic Resonance Imaging System recall (Z-2062-2021)GE Healthcare, LLC2021-07-12

PMA approvals by this applicant

RecordFirmDate
Senographe Pristina 3D (P130020/S005)GE Healthcare2025-11-21
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
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