Imager, Ultrasonic Obstetric-gynecologic

Product Code: HEM

Obstetrics/Gynecology Diagnostic Ultrasound Devices

Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 884.2225


Radiation TypeAcoustic
Radition SafetyAbbreviated
Annual ReportsNo

Products Classified as HEM

3911Imager, Ultrasonic Obstetric-gynecologicObstetric-gynecologic Ultrasonic Imager.

Total Product Life Cycle (TPLC) Devices

3911Imager, Ultrasonic Obstetric-gynecologicObstetric-gynecologic Ultrasonic Imager.

Pre-market Notifications for HEM

K951393ABACUS OB ULTRASOUNG COMPUTER SOFTWARESOLOMON TECHNOLOGY LABS
K942490BABE COMPUTER POGRAM FOR OBSTETRIC ULTRASOUNDMEDICAL SOFT, INC.
K910426SDU 500 DIAGNOSTIC ULTRASOUND INSTRUMENTSHIMADZU MEDICAL SYSTEMS
K905000ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCERCOROMETRICS MEDICAL SYSTEMS, INC.
K900505SONOACE 88 PORTABLE ULTRASOUND SCANNERMEDISON CO., LTD.
K900271MODEL OB-500 FETAL GROWTH ANALYSIS & OPTION OBLINKDIGISONICS, INC.
K890637EXTENDED OBSTETRICS SOFTWARE COMPUTATION PACKAGEELSCINT, INC.
K881329FETAL DOPPLER FOR ULTRAMARK 4 AND 8ADVANCED TECHNOLOGY LABORATORIES, INC.
K881185ANNULAR ARRAY PROBES FOR ARTIS 3200 DIAG. ULTRA.PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K880900SSD-620 LINEAR/CONVEX ARRAY SECTOR SCANNERCOROMETRICS MEDICAL SYSTEMS, INC.
K862627SONORANGER TRANSVAGINAL PROBEAUSONICS PTY LTD.
K862364NEEDLE GUIDE (FOR ULTRASOUND TRANSDUCERS)SWEMED LABORATORIES, INC.
K861931645OB SECTOR/LINEAR ULTRASOUND SCANNERGE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K853407INTRA VAGINAL TRANSDUCERADVANCED TECHNOLOGY LABORATORIES, INC.
K852439FETA SCAN 1000 OBSTETRICAL IMAGERINTERNATIONAL BIOMEDICS, INC.

Global Unique Device Identification Database

17350025911677Imager, Ultrasonic Obstetric-Gynecologic
17350025911653Imager, Ultrasonic Obstetric-Gynecologic
17350025911646Imager, Ultrasonic Obstetric-Gynecologic

Maude Adverse Events

SDU-450XLSHIMADZU MEDICAL SYSTEMS2012-09-20

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