Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Obstetrical and Gynecological Monitoring DevicesCFR Sub-Part
- IYMSystem, Telethermographic, Infrared3Product Code
- KXZSystem, Thermographic, Liquid Crystal, Powered (Adjunctive Use)3Product Code
- KYASystem, Thermographic, Liquid Crystal, Nonpowered (Adjunctive Use)1Product Code
- LHMSystem, Thermographic, Liquid Crystal1Product Code
- LHPSystem, Telethermographic (Sole Diagnostic Screen)3Product Code
- LHQSystem, Telethermographic (Adjunctive Use)1Product Code
- LHRSystem, Thermographic, Liquid Crystal (Sole Diagnostic Screen)3Product Code
- LXEDoppler, Fetal, Ultrasound2Product Code
- MAAMonitor, Fetal Doppler Ultrasound2Product Code
- K102138ULTRASONIC TABLETOP DOPPLER; ULTRASONIC TABLETOP DOPPLER2Cleared 510(K)
- K090499LIFEDOP MODEL, L350R2Cleared 510(K)
- K915138GE SONOCHROME2Cleared 510(K)
- K905536FETAL DOPPLER2Cleared 510(K)
- K904600L582 TRANSDUCER2Cleared 510(K)
- K905456L328 TRANSDUCER2Cleared 510(K)
- K904951S5192R TRANSDUCER2Cleared 510(K)
- K895909SONICAID MODEL VASOFLO 42Cleared 510(K)
- K894992QUANTUM QAD ANGIODYNOGRAPH ULTRASOUND SYSTEM2Cleared 510(K)
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
GE SONOCHROME
- Page Type
- Cleared 510(K)
- 510(k) Number
- K915138
- 510(k) Type
- Traditional
- Applicant
- GE MEDICAL SYSTEMS
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 10/20/1992
- Days to Decision
- 342 days
- Submission Type
- Summary