Atlas FDA

CCD CAMERA, MODEL 9000

FDA 510(k) clearance K990066 · decided 1999-03-17

Clearance details

K-number
K990066
Device name
CCD CAMERA, MODEL 9000
Applicant
Camtronics, Ltd.
Decision
Substantially Equivalent
Date received
1999-01-08
Decision date
1999-03-17
Days to decision
68 days
Clearance type
Traditional
Product code
LMA
Device class
2
Regulation number
892.2030
Medical specialty
Radiology
Advisory committee
Radiology
Location
Hartland, WI, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
GE Stereotaxy Positioner, model 2405544-2, for use with Senographe DS Full Field Mammograp recall (Z-2146-2008)GE Healthcare2008-09-26
GE Stereotaxy Positioner, model 2405544-3, for use with Senographe DS Full Field Mammograp recall (Z-2147-2008)GE Healthcare2008-09-26