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
- NRZAblation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided3Product Code
- OVXWater Immersion Labor PoolNProduct Code
- PASRf/Microwave Hyperthermia System, Cancer TreatmentFProduct Code
- HHYProsthesis, Suture, Cerclage3Product Code
- LHDDevice, Fertility Diagnostic, ProceptiveUProduct Code
- K200163Ava Fertility TrackerUCleared 510(K)
- K122337OVUSENSEUCleared 510(K)
- K102499DUOFERTILITYUCleared 510(K)
- K050094LADY COMP USAUCleared 510(K)
- K030961MICROLIFE DIGITAL BASAL THERMOMETER, MODEL MT 1921UCleared 510(K)
- K021978PETIT SOPHIAUCleared 510(K)
- K002726TCOYF FERTILITY SOFTWARE VERSION 1.0UCleared 510(K)
- K952756MEDI-AID BASAL THERMOMETERUCleared 510(K)
- K945427B-D DIGITAL THERMOMETERUCleared 510(K)
- K904211BIOSELF 2000 FERTILITY INDICATORUCleared 510(K)
- K901512L SOPHIAUCleared 510(K)
- K880618FERTILITY FORECASTER COMPUTER PROGRAMUCleared 510(K)
- K870999GENDER CHOICE INFORMATION KIT, FEMALE AND MALEUCleared 510(K)
- K870528OVU-TRAC OVULATION TIMING KITUCleared 510(K)
- K852194MODEL MT-50 DIGITAL MEMORY FEVER & BASAL THERMOMETUCleared 510(K)
- K852801BIOCHRON FERTILITY INDICATORUCleared 510(K)
- K845009RABBIT-PERSONAL COMPUTER FOR WOMENUCleared 510(K)
- K844043OVUDATEUCleared 510(K)
- K843699BIOSELF TM 110UCleared 510(K)
- K823463RIGHT TIME RHYTHM CLOCKUCleared 510(K)
- K823209BIOSELF 101UCleared 510(K)
- K821507SYMPTOTHERM 8 FERTILITY INDICATORUCleared 510(K)
- K813497RHYTHM WHEELUCleared 510(K)
- LLQCap, Cervical, Contraceptive3Product Code
- LLXCatheter, Sampling, Chorionic Villus3Product Code
- LOBDilator, Cervical, Synthetic, Osmotic, Pregnancy Termination3Product Code
- LTAFluid, Hysteroscopy3Product Code
- LTYFluid, Cytological Collection3Product Code
- MCIGraft, Vascular, Hemodialysis Access, Synthetic/Biological Composite3Product Code
- MCNBarrier, Absorbable, Adhesion3Product Code
- MCPStimulator, Fetal, Acoustic3Product Code
- MGIAspirator, Ultrasonic3Product Code
- MKNCatheter, Balloon, Transcervical3Product Code
- MMAOximeter, Fetal Pulse3Product Code
- MNBDevice, Thermal Ablation, Endometrial3Product Code
- MPRStent, Bladder, FetalFProduct Code
- MPTContraception CalculatorUProduct Code
- MWMSensor, Electro-Optical (For Cervical Cancer)3Product Code
- PKFD And C TrayNProduct Code
- QLHSystem, Intravaginal, For Controlled Release Of Drug Substance, Cder Or Cber LedNProduct Code
- QRZExternal Condom For Anal Intercourse Or Vaginal Intercourse2Product Code
- Submissions with No Product CodeMiscellaneous
- 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
- 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
L SOPHIA
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K901512
- 510(k) Type
- Traditional
- Applicant
- NISHITOMO CO., INC.
- Country
- Japan
- FDA Decision
- Substantially Equivalent
- Decision Date
- 7/20/1990
- Days to Decision
- 113 days