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
- MiscellaneousMiscellaneous
- Subpart B—Clinical Chemistry Test SystemsCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Obstetrical and Gynecological Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—Obstetrical and Gynecological Monitoring DevicesCFR Sub-Part
- HEQMonitor, Pressure, Arterial, Fetal, Ultrasonic2Product Code
- HEIMonitor, Heart-Valve Movement, Fetal, Ultrasonic2Product Code
- HEJMonitor, Hemic Sound, Ultrasonic2Product Code
- HEKMonitor, Heart Sound, Fetal, Ultrasonic2Product Code
- HELMonitor, Heart Rate, Fetal, Ultrasonic2Product Code
- HEMImager, Ultrasonic Obstetric-Gynecologic2Product Code
- K951393ABACUS OB ULTRASOUNG COMPUTER SOFTWARE2Cleared 510(K)
- K942490BABE COMPUTER POGRAM FOR OBSTETRIC ULTRASOUND2Cleared 510(K)
- K910426SDU 500 DIAGNOSTIC ULTRASOUND INSTRUMENT2Cleared 510(K)
- K905000ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER2Cleared 510(K)
- K900505SONOACE 88 PORTABLE ULTRASOUND SCANNER2Cleared 510(K)
- K900271MODEL OB-500 FETAL GROWTH ANALYSIS & OPTION OBLINK2Cleared 510(K)
- K890637EXTENDED OBSTETRICS SOFTWARE COMPUTATION PACKAGE2Cleared 510(K)
- K881329FETAL DOPPLER FOR ULTRAMARK 4 AND 82Cleared 510(K)
- K885061SIEMENS INTRAVAGINAL TRANSDUCER2Cleared 510(K)
- K881185ANNULAR ARRAY PROBES FOR ARTIS 3200 DIAG. ULTRA.2Cleared 510(K)
- K880900SSD-620 LINEAR/CONVEX ARRAY SECTOR SCANNER2Cleared 510(K)
- K862364NEEDLE GUIDE (FOR ULTRASOUND TRANSDUCERS)2Cleared 510(K)
- K862627SONORANGER TRANSVAGINAL PROBE2Cleared 510(K)
- K861931645OB SECTOR/LINEAR ULTRASOUND SCANNER2Cleared 510(K)
- K8602335 MHZ INTRACAVITARY PROBE, MODEL H4222V2Cleared 510(K)
- K8537115.0 MHZ INTRACAVITARY SECTOR PROBE2Cleared 510(K)
- K853407INTRA VAGINAL TRANSDUCER2Cleared 510(K)
- K851902MODEL U-1000 ULTRASONIC SCANNER2Cleared 510(K)
- K852439FETA SCAN 1000 OBSTETRICAL IMAGER2Cleared 510(K)
- K842261OB ULTRASOUND LINEAR SCANNER 6302Cleared 510(K)
- K840623OBSTETRICAL ULTRASOUND COMPUTER2Cleared 510(K)
- K834088GEL-SCAN DIAGNOSTIC ULTRASOUND COUPLING2Cleared 510(K)
- K833488SONICOMP2Cleared 510(K)
- K811520GRAYLINE IMAGING SYSTEM2Cleared 510(K)
- K810305DATASON DB ULTRASOUND IMAGING SYSTEM2Cleared 510(K)
- K780876ULTRASONIC IMAGER2Cleared 510(K)
- K771816ROCHE AXISCAN 52Cleared 510(K)
- K770644ULTRASOUND B-SCANNING SYSTEM2Cleared 510(K)
- K761052REAL TIME OBSTETRICAL ULTRASONIC SCANNER2Cleared 510(K)
- K760874V.I. OCTOSON ULTRASONIC SYSTEM2Cleared 510(K)
- HENCaliper, Fetal Head, Ultrasonic2Product Code
- HEOAnalyzer, Data, Obstetric3Product Code
- HEPMonitor, Blood-Flow, Ultrasonic2Product Code
- HFMMonitor, Uterine Contraction, External (For Use In Clinic)2Product Code
- HFNTransducer, Pressure, Intrauterine2Product Code
- HFORecorder, Pressure, Intrauterine2Product Code
- HFPMonitor, Phonocardiographic, Fetal2Product Code
- HGLTransducer, Ultrasonic, Obstetric2Product Code
- HGMSystem, Monitoring, Perinatal2Product Code
- HGNStethoscope, Fetal1Product Code
- HGOMonitor, Electroencephalographic, Fetal (And Accessories)3Product Code
- HGPElectrode, Circular (Spiral), Scalp And Applicator2Product Code
- HGSCatheter, Intrauterine And Introducer2Product Code
- HHJLocator, Intracorporeal Device, Ultrasonic, Obstetric-Gynecologic2Product Code
- HHXHolograph, Fetal, Acoustical2Product Code
- HIQElectrode, Clip, Fetal Scalp (And Applicator)3Product Code
- KNGMonitor, Ultrasonic, Fetal2Product Code
- KXNMonitor, Cardiac, Fetal2Product Code
- KXOMonitor, Pressure, Intrauterine2Product Code
- LQKHome Uterine Activity Monitor2Product Code
- MOHMonitor, Heart Rate, Fetal, Non-Stress Test (Home Use)2Product Code
- NHMSheet, Recording, Breast Examination2Product Code
- NKASystem, Documentation, Breast Lesion2Product Code
- OSPUterine Electromyographic Monitor2Product Code
- NPBSystem, Monitoring, For Progress Of Labor2Product Code
- Subpart D—Cardiovascular Prosthetic DevicesCFR Sub-Part
- Subpart D—Obstetrical and Gynecological Prosthetic DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Obstetrical and Gynecological Surgical DevicesCFR Sub-Part
- Subpart F—Obstetrical and Gynecological Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—Assisted Reproduction DevicesCFR Sub-Part
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
ROCHE AXISCAN 5
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K771816
- 510(k) Type
- Traditional
- Applicant
- ROCHE MEDICAL ELECTRONICS, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 10/19/1977
- Days to Decision
- 22 days