Atlas FDA

SFX-90 TABLE/SPOTFILMER W/FLUORICON L200

FDA 510(k) clearance K801320 · decided 1980-07-21

Clearance details

K-number
K801320
Device name
SFX-90 TABLE/SPOTFILMER W/FLUORICON L200
Applicant
General Electric Co.
Decision
Substantially Equivalent
Date received
1980-06-03
Decision date
1980-07-21
Days to decision
48 days
Clearance type
Traditional
Product code
JAA
Device class
2
Regulation number
892.1650
Medical specialty
Radiology
Advisory committee
Radiology
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Table Patient Step on RFX/SFX, Legacy, and Precision 500D systems recall (Z-2179-2017)GE Healthcare, LLC2017-05-22
Video Monitor Suspensions that may be on the following Fluoroscopic and Radiographic X-Ray recall (Z-0804-2014)GE Healthcare, LLC2014-01-21
GE Healthcare, Precision 500D, Legacy, RFX, and SFX X. This table is intended for use in a recall (Z-0012-2014)GE Healthcare, LLC2013-10-17
Monitor suspensions used with Advantx Legacy, RFX Classical, SFX-90, Model # 46-240838G2, recall (Z-0200-2009)GE Healthcare2008-10-27
GE Single 15 inch TV Monitor Suspension with Rail, Model 46-240485P1, Catalog number B0256 recall (Z-0850-04)General Electric Med Systems2004-07-20
GE Single 15 inch TV Monitor Suspension for XT Bridge, Model 46-240485P2, Catalog Number B recall (Z-0851-04)General Electric Med Systems2004-07-20
GE Single 20 inch TV Monitor Suspension with Rail, Model 46-240485P5, Catalog Number B2056 recall (Z-0852-04)General Electric Med Systems2004-07-20
GE Single 20 inch TV Monitor Suspension for XT Bridge, Model 46-240485P6, Catalog Number B recall (Z-0853-04)General Electric Med Systems2004-07-20

PMA approvals by this applicant

RecordFirmDate
GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S017)General Electric Co.1988-07-29
GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S013)General Electric Co.1988-07-15
GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S016)General Electric Co.1988-06-30
GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S014)General Electric Co.1988-05-05
GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S015)General Electric Co.1988-05-02
GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S012)General Electric Co.1987-11-25
GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S011)General Electric Co.1987-06-18
GE SIGNA MAGNETIC RESONANCE DIAGNOSTIC IMAGING SYS (P830074/S010)General Electric Co.1987-03-30