Product code HEM— Obstetrics/Gynecology

FDA has cleared 30 devices under product code HEM between 1976 and 1995, filed by 24 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 19952 clearances
• 19912 clearances
• 19902 clearances
• 19893 clearances
• 19882 clearances
• 19864 clearances
• 19854 clearances
• 19842 clearances
• 19832 clearances
• 19812 clearances
• 19781 clearance
• 19772 clearances
• 19762 clearances

• General Electric Co.4 clearances
• Ge Medical Systems Information Technologies2 clearances
• Corometrics Medical Systems, Inc.2 clearances
• Advanced Technology Laboratories, Inc.2 clearances
• Whs Products, Inc.1 clearance
• Unirad Corp.1 clearance
• Swemed Laboratories, Inc.1 clearance
• Sonics Research Corp.1 clearance
• Sonicaid, Inc.1 clearance
• Solomon Technology Labs1 clearance

• K951393 — ABACUS OB ULTRASOUNG COMPUTER SOFTWARESolomon Technology Labs·1995-05-01
• K942490 — BABE COMPUTER POGRAM FOR OBSTETRIC ULTRASOUNDMedical Soft, Inc.·1995-02-15
• K910426 — SDU 500 DIAGNOSTIC ULTRASOUND INSTRUMENTShimadzu Medical Systems·1991-06-06
• K905000 — ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCERCorometrics Medical Systems, Inc.·1991-01-31
• K900505 — SONOACE 88 PORTABLE ULTRASOUND SCANNERMedison Co., Ltd.·1990-08-10
• K900271 — MODEL OB-500 FETAL GROWTH ANALYSIS & OPTION OBLINKDigisonics, Inc.·1990-04-19
• K890637 — EXTENDED OBSTETRICS SOFTWARE COMPUTATION PACKAGEElscint, Inc.·1989-06-12
• K881329 — FETAL DOPPLER FOR ULTRAMARK 4 AND 8Advanced Technology Laboratories, Inc.·1989-04-14
• K885061 — SIEMENS INTRAVAGINAL TRANSDUCERSiemens Medical Solutions USA, Inc.·1989-02-23
• K880900 — SSD-620 LINEAR/CONVEX ARRAY SECTOR SCANNERCorometrics Medical Systems, Inc.·1988-06-01
• K881185 — ANNULAR ARRAY PROBES FOR ARTIS 3200 DIAG. ULTRA.Philips Medical Systems (Cleveland), Inc.·1988-06-01
• K862364 — NEEDLE GUIDE (FOR ULTRASOUND TRANSDUCERS)Swemed Laboratories, Inc.·1986-08-19
• K862627 — SONORANGER TRANSVAGINAL PROBEAusonics Pty , Ltd.·1986-08-01
• K861931 — 645OB SECTOR/LINEAR ULTRASOUND SCANNERGe Medical Systems Information Technologies·1986-07-31
• K860233 — 5 MHZ INTRACAVITARY PROBE, MODEL H4222VGeneral Electric Co.·1986-06-02
• K853711 — 5.0 MHZ INTRACAVITARY SECTOR PROBEGeneral Electric Co.·1985-12-18
• K851902 — MODEL U-1000 ULTRASONIC SCANNERFukuda Denshi USA, Inc.·1985-09-27
• K853407 — INTRA VAGINAL TRANSDUCERAdvanced Technology Laboratories, Inc.·1985-09-27
• K852439 — FETA SCAN 1000 OBSTETRICAL IMAGERInternational Biomedics, Inc.·1985-08-30
• K842261 — OB ULTRASOUND LINEAR SCANNER 630Ge Medical Systems Information Technologies·1984-09-19
• K840623 — OBSTETRICAL ULTRASOUND COMPUTERR & S Systems·1984-05-11
• K834088 — GEL-SCAN DIAGNOSTIC ULTRASOUND COUPLINGWhs Products, Inc.·1983-12-15
• K833488 — SONICOMPSonicaid, Inc.·1983-11-28
• K811520 — GRAYLINE IMAGING SYSTEMSonics Research Corp.·1981-07-02
• K810305 — DATASON DB ULTRASOUND IMAGING SYSTEMGeneral Electric Co.·1981-03-13
• K780876 — ULTRASONIC IMAGERAir-Shields, Inc.·1978-06-27
• K771816 — ROCHE AXISCAN 5Roche Medical Electronics, Inc.·1977-10-19
• K770644 — ULTRASOUND B-SCANNING SYSTEMUnirad Corp.·1977-04-14
• K760874 — V.I. OCTOSON ULTRASONIC SYSTEMGeneral Electric Co.·1976-12-16
• K761052 — REAL TIME OBSTETRICAL ULTRASONIC SCANNERSmithkline Diagnostics, Inc.·1976-12-16