Atlas FDA

FLUORICON 500 IMAGE INTENSIFIERS

FDA 510(k) clearance K770094 · decided 1977-01-21

Clearance details

K-number
K770094
Device name
FLUORICON 500 IMAGE INTENSIFIERS
Applicant
General Electric Co.
Decision
Substantially Equivalent
Date received
1977-01-17
Decision date
1977-01-21
Days to decision
4 days
Clearance type
Traditional
Product code
EAM
Device class
1
Regulation number
892.1960
Medical specialty
Radiology
Advisory committee
Radiology
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

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

RecordFirmDate
ULTRA-VISION MAMMOGRAPHY DETAIL, ULTRA-VISION MAMMOGRAPHY FAST DETAIL (K974423)Sterling Diagnostic Imaging, Inc.1997-12-22
MD100 & MM150 (K963913)Konica Medical Corp.1997-10-08
JPI INTENSIFYING SCREEN (K954161)Jpi Healthcare Co, Ltd.1996-02-02
KYOKKO SPEC-SERIES INTENSIFY SCREENS-SPEC,SUPER SPEC (K943821)Fujifilm Medical System U.S.A., Inc.1994-08-22
FUJI UM MAMMO SERIES INTENSIFY SCREENS: (K943822)Fujifilm Medical System U.S.A., Inc.1994-08-22
FUJI FG SERIES INTENSIFYING SCREENS: FG-3-4-8-12 (K943823)Fujifilm Medical System U.S.A., Inc.1994-08-22
KYOKKO GREEN SERIES INTENSIFYING SCREENS (K942235)Fujifilm Medical System U.S.A., Inc.1994-08-17
FUJI HG-M INTENSIFYING SCREEN (K943425)Fujifilm Medical System U.S.A., Inc.1994-08-17
KYOKKO BLUE SERIES INTENSIFYING SCREENS (K942805)Fujifilm Medical System U.S.A., Inc.1994-07-29
KODAK INSIGHT TWIN-LOAD INSERT (K942909)Eastman Kodak Company1994-07-29
KYOKKO UM SERIES INTENSIFYING SCREEN (K942399)Fujifilm Medical System U.S.A., Inc.1994-06-10
RAREX GREEN FAST (K941023)Mci Optonix, Inc.1994-03-30

Recalls involving this device

No recalls on record reference this clearance.

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