FDA Product Code
FDA Product Code HEM — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Obstetrics/Gynecology
- 21 CFR Citation
- 884.2225
510(k) Clearances — 30 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K951393 | ABACUS OB ULTRASOUNG COMPUTER SOFTWARE | Solomon Technology Labs | 1995-05-01 | Traditional | PDF ↗ |
| K942490 | BABE COMPUTER POGRAM FOR OBSTETRIC ULTRASOUND | Medical Soft, Inc. | 1995-02-15 | Traditional | PDF ↗ |
| K910426 | SDU 500 DIAGNOSTIC ULTRASOUND INSTRUMENT | Shimadzu Medical Systems | 1991-06-06 | Traditional | PDF ↗ |
| K905000 | ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER | Corometrics Medical Systems, Inc. | 1991-01-31 | Traditional | PDF ↗ |
| K900505 | SONOACE 88 PORTABLE ULTRASOUND SCANNER | Medison Co., Ltd. | 1990-08-10 | Traditional | PDF ↗ |
| K900271 | MODEL OB-500 FETAL GROWTH ANALYSIS & OPTION OBLINK | Digisonics, Inc. | 1990-04-19 | Traditional | PDF ↗ |
| K890637 | EXTENDED OBSTETRICS SOFTWARE COMPUTATION PACKAGE | Elscint, Inc. | 1989-06-12 | Traditional | PDF ↗ |
| K881329 | FETAL DOPPLER FOR ULTRAMARK 4 AND 8 | Advanced Technology Laboratories, Inc. | 1989-04-14 | Traditional | PDF ↗ |
| K885061 | SIEMENS INTRAVAGINAL TRANSDUCER | Siemens Medical Solutions USA, Inc. | 1989-02-23 | Traditional | PDF ↗ |
| K881185 | ANNULAR ARRAY PROBES FOR ARTIS 3200 DIAG. ULTRA. | Philips Medical Systems (Cleveland), Inc. | 1988-06-01 | Traditional | PDF ↗ |
| K880900 | SSD-620 LINEAR/CONVEX ARRAY SECTOR SCANNER | Corometrics Medical Systems, Inc. | 1988-06-01 | Traditional | PDF ↗ |
| K862364 | NEEDLE GUIDE (FOR ULTRASOUND TRANSDUCERS) | Swemed Laboratories, Inc. | 1986-08-19 | Traditional | PDF ↗ |
| K862627 | SONORANGER TRANSVAGINAL PROBE | Ausonics Pty , Ltd. | 1986-08-01 | Traditional | PDF ↗ |
| K861931 | 645OB SECTOR/LINEAR ULTRASOUND SCANNER | Ge Medical Systems Information Technologies | 1986-07-31 | Traditional | PDF ↗ |
| K860233 | 5 MHZ INTRACAVITARY PROBE, MODEL H4222V | General Electric Co. | 1986-06-02 | Traditional | PDF ↗ |
| K853711 | 5.0 MHZ INTRACAVITARY SECTOR PROBE | General Electric Co. | 1985-12-18 | Traditional | PDF ↗ |
| K853407 | INTRA VAGINAL TRANSDUCER | Advanced Technology Laboratories, Inc. | 1985-09-27 | Traditional | PDF ↗ |
| K851902 | MODEL U-1000 ULTRASONIC SCANNER | Fukuda Denshi USA, Inc. | 1985-09-27 | Traditional | PDF ↗ |
| K852439 | FETA SCAN 1000 OBSTETRICAL IMAGER | International Biomedics, Inc. | 1985-08-30 | Traditional | PDF ↗ |
| K842261 | OB ULTRASOUND LINEAR SCANNER 630 | Ge Medical Systems Information Technologies | 1984-09-19 | Traditional | PDF ↗ |
| K840623 | OBSTETRICAL ULTRASOUND COMPUTER | R & S Systems | 1984-05-11 | Traditional | PDF ↗ |
| K834088 | GEL-SCAN DIAGNOSTIC ULTRASOUND COUPLING | Whs Products, Inc. | 1983-12-15 | Traditional | PDF ↗ |
| K833488 | SONICOMP | Sonicaid, Inc. | 1983-11-28 | Traditional | PDF ↗ |
| K811520 | GRAYLINE IMAGING SYSTEM | Sonics Research Corp. | 1981-07-02 | Traditional | PDF ↗ |
| K810305 | DATASON DB ULTRASOUND IMAGING SYSTEM | General Electric Co. | 1981-03-13 | Traditional | PDF ↗ |
| K780876 | ULTRASONIC IMAGER | Air-Shields, Inc. | 1978-06-27 | Traditional | PDF ↗ |
| K771816 | ROCHE AXISCAN 5 | Roche Medical Electronics, Inc. | 1977-10-19 | Traditional | PDF ↗ |
| K770644 | ULTRASOUND B-SCANNING SYSTEM | Unirad Corp. | 1977-04-14 | Traditional | PDF ↗ |
| K761052 | REAL TIME OBSTETRICAL ULTRASONIC SCANNER | Smithkline Diagnostics, Inc. | 1976-12-16 | Traditional | PDF ↗ |
| K760874 | V.I. OCTOSON ULTRASONIC SYSTEM | General Electric Co. | 1976-12-16 | Traditional | PDF ↗ |
Product code HEM · Class II · Obstetrics/Gynecology. Data: openFDA.