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Miscellaneous
Subpart B—Clinical Chemistry Test Systems
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart B—Obstetrical and Gynecological Diagnostic Devices
CFR Sub-Part
Subpart C—Cardiovascular Monitoring Devices
CFR Sub-Part
Subpart C—Obstetrical and Gynecological Monitoring Devices
CFR Sub-Part
HEQ
Monitor, Pressure, Arterial, Fetal, Ultrasonic
2
Product Code
HEI
Monitor, Heart-Valve Movement, Fetal, Ultrasonic
2
Product Code
HEJ
Monitor, Hemic Sound, Ultrasonic
2
Product Code
HEK
Monitor, Heart Sound, Fetal, Ultrasonic
2
Product Code
HEL
Monitor, Heart Rate, Fetal, Ultrasonic
2
Product Code
HEM
Imager, Ultrasonic Obstetric-Gynecologic
2
Product Code
K
95
1393
ABACUS OB ULTRASOUNG COMPUTER SOFTWARE
2
Cleared 510(K)
K
94
2490
BABE COMPUTER POGRAM FOR OBSTETRIC ULTRASOUND
2
Cleared 510(K)
K
91
0426
SDU 500 DIAGNOSTIC ULTRASOUND INSTRUMENT
2
Cleared 510(K)
K
90
5000
ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER
2
Cleared 510(K)
K
90
0505
SONOACE 88 PORTABLE ULTRASOUND SCANNER
2
Cleared 510(K)
K
90
0271
MODEL OB-500 FETAL GROWTH ANALYSIS & OPTION OBLINK
2
Cleared 510(K)
K
89
0637
EXTENDED OBSTETRICS SOFTWARE COMPUTATION PACKAGE
2
Cleared 510(K)
K
88
1329
FETAL DOPPLER FOR ULTRAMARK 4 AND 8
2
Cleared 510(K)
K
88
5061
SIEMENS INTRAVAGINAL TRANSDUCER
2
Cleared 510(K)
K
88
1185
ANNULAR ARRAY PROBES FOR ARTIS 3200 DIAG. ULTRA.
2
Cleared 510(K)
K
88
0900
SSD-620 LINEAR/CONVEX ARRAY SECTOR SCANNER
2
Cleared 510(K)
K
86
2364
NEEDLE GUIDE (FOR ULTRASOUND TRANSDUCERS)
2
Cleared 510(K)
K
86
2627
SONORANGER TRANSVAGINAL PROBE
2
Cleared 510(K)
K
86
1931
645OB SECTOR/LINEAR ULTRASOUND SCANNER
2
Cleared 510(K)
K
86
0233
5 MHZ INTRACAVITARY PROBE, MODEL H4222V
2
Cleared 510(K)
K
85
3711
5.0 MHZ INTRACAVITARY SECTOR PROBE
2
Cleared 510(K)
K
85
3407
INTRA VAGINAL TRANSDUCER
2
Cleared 510(K)
K
85
1902
MODEL U-1000 ULTRASONIC SCANNER
2
Cleared 510(K)
K
85
2439
FETA SCAN 1000 OBSTETRICAL IMAGER
2
Cleared 510(K)
K
84
2261
OB ULTRASOUND LINEAR SCANNER 630
2
Cleared 510(K)
K
84
0623
OBSTETRICAL ULTRASOUND COMPUTER
2
Cleared 510(K)
K
83
4088
GEL-SCAN DIAGNOSTIC ULTRASOUND COUPLING
2
Cleared 510(K)
K
83
3488
SONICOMP
2
Cleared 510(K)
K
81
1520
GRAYLINE IMAGING SYSTEM
2
Cleared 510(K)
K
81
0305
DATASON DB ULTRASOUND IMAGING SYSTEM
2
Cleared 510(K)
K
78
0876
ULTRASONIC IMAGER
2
Cleared 510(K)
K
77
1816
ROCHE AXISCAN 5
2
Cleared 510(K)
K
77
0644
ULTRASOUND B-SCANNING SYSTEM
2
Cleared 510(K)
K
76
1052
REAL TIME OBSTETRICAL ULTRASONIC SCANNER
2
Cleared 510(K)
K
76
0874
V.I. OCTOSON ULTRASONIC SYSTEM
2
Cleared 510(K)
HEN
Caliper, Fetal Head, Ultrasonic
2
Product Code
HEO
Analyzer, Data, Obstetric
3
Product Code
HEP
Monitor, Blood-Flow, Ultrasonic
2
Product Code
HFM
Monitor, Uterine Contraction, External (For Use In Clinic)
2
Product Code
HFN
Transducer, Pressure, Intrauterine
2
Product Code
HFO
Recorder, Pressure, Intrauterine
2
Product Code
HFP
Monitor, Phonocardiographic, Fetal
2
Product Code
HGL
Transducer, Ultrasonic, Obstetric
2
Product Code
HGM
System, Monitoring, Perinatal
2
Product Code
HGN
Stethoscope, Fetal
1
Product Code
HGO
Monitor, Electroencephalographic, Fetal (And Accessories)
3
Product Code
HGP
Electrode, Circular (Spiral), Scalp And Applicator
2
Product Code
HGS
Catheter, Intrauterine And Introducer
2
Product Code
HHJ
Locator, Intracorporeal Device, Ultrasonic, Obstetric-Gynecologic
2
Product Code
HHX
Holograph, Fetal, Acoustical
2
Product Code
HIQ
Electrode, Clip, Fetal Scalp (And Applicator)
3
Product Code
KNG
Monitor, Ultrasonic, Fetal
2
Product Code
KXN
Monitor, Cardiac, Fetal
2
Product Code
KXO
Monitor, Pressure, Intrauterine
2
Product Code
LQK
Home Uterine Activity Monitor
2
Product Code
MOH
Monitor, Heart Rate, Fetal, Non-Stress Test (Home Use)
2
Product Code
NHM
Sheet, Recording, Breast Examination
2
Product Code
NKA
System, Documentation, Breast Lesion
2
Product Code
OSP
Uterine Electromyographic Monitor
2
Product Code
NPB
System, Monitoring, For Progress Of Labor
2
Product Code
Subpart D—Cardiovascular Prosthetic Devices
CFR Sub-Part
Subpart D—Obstetrical and Gynecological Prosthetic Devices
CFR Sub-Part
Subpart D—Physical Medicine Prosthetic Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Obstetrical and Gynecological Surgical Devices
CFR Sub-Part
Subpart F—Obstetrical and Gynecological Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Subpart G—Assisted Reproduction Devices
CFR Sub-Part
Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 16 August 2024 at 11:05 pm
OB
/
subpart-c—obstetrical-and-gynecological-monitoring-devices
/
HEM
/
K760874
View Source
V.I. OCTOSON ULTRASONIC SYSTEM
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K760874
510(k) Type
Traditional
Applicant
GENERAL ELECTRIC CO.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/16/1976
Days to Decision
59 days
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Miscellaneous
Subpart B—Clinical Chemistry Test Systems
Subpart B—Diagnostic Devices
Subpart B—Obstetrical and Gynecological Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
Subpart C—Obstetrical and Gynecological Monitoring Devices
HEQ
Monitor, Pressure, Arterial, Fetal, Ultrasonic
HEI
Monitor, Heart-Valve Movement, Fetal, Ultrasonic
HEJ
Monitor, Hemic Sound, Ultrasonic
HEK
Monitor, Heart Sound, Fetal, Ultrasonic
HEL
Monitor, Heart Rate, Fetal, Ultrasonic
HEM
Imager, Ultrasonic Obstetric-Gynecologic
K
95
1393
ABACUS OB ULTRASOUNG COMPUTER SOFTWARE
K
94
2490
BABE COMPUTER POGRAM FOR OBSTETRIC ULTRASOUND
K
91
0426
SDU 500 DIAGNOSTIC ULTRASOUND INSTRUMENT
K
90
5000
ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER
K
90
0505
SONOACE 88 PORTABLE ULTRASOUND SCANNER
K
90
0271
MODEL OB-500 FETAL GROWTH ANALYSIS & OPTION OBLINK
K
89
0637
EXTENDED OBSTETRICS SOFTWARE COMPUTATION PACKAGE
K
88
1329
FETAL DOPPLER FOR ULTRAMARK 4 AND 8
K
88
5061
SIEMENS INTRAVAGINAL TRANSDUCER
K
88
1185
ANNULAR ARRAY PROBES FOR ARTIS 3200 DIAG. ULTRA.
K
88
0900
SSD-620 LINEAR/CONVEX ARRAY SECTOR SCANNER
K
86
2364
NEEDLE GUIDE (FOR ULTRASOUND TRANSDUCERS)
K
86
2627
SONORANGER TRANSVAGINAL PROBE
K
86
1931
645OB SECTOR/LINEAR ULTRASOUND SCANNER
K
86
0233
5 MHZ INTRACAVITARY PROBE, MODEL H4222V
K
85
3711
5.0 MHZ INTRACAVITARY SECTOR PROBE
K
85
3407
INTRA VAGINAL TRANSDUCER
K
85
1902
MODEL U-1000 ULTRASONIC SCANNER
K
85
2439
FETA SCAN 1000 OBSTETRICAL IMAGER
K
84
2261
OB ULTRASOUND LINEAR SCANNER 630
K
84
0623
OBSTETRICAL ULTRASOUND COMPUTER
K
83
4088
GEL-SCAN DIAGNOSTIC ULTRASOUND COUPLING
K
83
3488
SONICOMP
K
81
1520
GRAYLINE IMAGING SYSTEM
K
81
0305
DATASON DB ULTRASOUND IMAGING SYSTEM
K
78
0876
ULTRASONIC IMAGER
K
77
1816
ROCHE AXISCAN 5
K
77
0644
ULTRASOUND B-SCANNING SYSTEM
K
76
1052
REAL TIME OBSTETRICAL ULTRASONIC SCANNER
K
76
0874
V.I. OCTOSON ULTRASONIC SYSTEM
HEN
Caliper, Fetal Head, Ultrasonic
HEO
Analyzer, Data, Obstetric
HEP
Monitor, Blood-Flow, Ultrasonic
HFM
Monitor, Uterine Contraction, External (For Use In Clinic)
HFN
Transducer, Pressure, Intrauterine
HFO
Recorder, Pressure, Intrauterine
HFP
Monitor, Phonocardiographic, Fetal
HGL
Transducer, Ultrasonic, Obstetric
HGM
System, Monitoring, Perinatal
HGN
Stethoscope, Fetal
HGO
Monitor, Electroencephalographic, Fetal (And Accessories)
HGP
Electrode, Circular (Spiral), Scalp And Applicator
HGS
Catheter, Intrauterine And Introducer
HHJ
Locator, Intracorporeal Device, Ultrasonic, Obstetric-Gynecologic
HHX
Holograph, Fetal, Acoustical
HIQ
Electrode, Clip, Fetal Scalp (And Applicator)
KNG
Monitor, Ultrasonic, Fetal
KXN
Monitor, Cardiac, Fetal
KXO
Monitor, Pressure, Intrauterine
LQK
Home Uterine Activity Monitor
MOH
Monitor, Heart Rate, Fetal, Non-Stress Test (Home Use)
NHM
Sheet, Recording, Breast Examination
NKA
System, Documentation, Breast Lesion
OSP
Uterine Electromyographic Monitor
NPB
System, Monitoring, For Progress Of Labor
Subpart D—Cardiovascular Prosthetic Devices
Subpart D—Obstetrical and Gynecological Prosthetic Devices
Subpart D—Physical Medicine Prosthetic Devices
Subpart D—Prosthetic Devices
Subpart E—Obstetrical and Gynecological Surgical Devices
Subpart F—Obstetrical and Gynecological Therapeutic Devices
Subpart F—Therapeutic Devices
Subpart G—Assisted Reproduction Devices
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
OB
/
subpart-c—obstetrical-and-gynecological-monitoring-devices
/
HEM
/
K760874
View Source
V.I. OCTOSON ULTRASONIC SYSTEM
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K760874
510(k) Type
Traditional
Applicant
GENERAL ELECTRIC CO.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/16/1976
Days to Decision
59 days