Product code HEM
- Device name
- Imager, Ultrasonic Obstetric-Gynecologic
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 2
- Regulation number
- 884.2225
- Review panel
- OB
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K951393 | ABACUS OB ULTRASOUNG COMPUTER SOFTWARE | Solomon Technology Labs | 1995-05-01 |
| K942490 | BABE COMPUTER POGRAM FOR OBSTETRIC ULTRASOUND | Medical Soft, Inc. | 1995-02-15 |
| K910426 | SDU 500 DIAGNOSTIC ULTRASOUND INSTRUMENT | Shimadzu Medical Systems | 1991-06-06 |
| K905000 | ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER | Corometrics Medical Systems, Inc. | 1991-01-31 |
| K900505 | SONOACE 88 PORTABLE ULTRASOUND SCANNER | Medison Co., Ltd. | 1990-08-10 |
| K900271 | MODEL OB-500 FETAL GROWTH ANALYSIS & OPTION OBLINK | Digisonics, Inc. | 1990-04-19 |
| K890637 | EXTENDED OBSTETRICS SOFTWARE COMPUTATION PACKAGE | Elscint, Inc. | 1989-06-12 |
| K881329 | FETAL DOPPLER FOR ULTRAMARK 4 AND 8 | Advanced Technology Laboratories, Inc. | 1989-04-14 |
| K885061 | SIEMENS INTRAVAGINAL TRANSDUCER | Siemens Medical Solutions USA, Inc. | 1989-02-23 |
| K881185 | ANNULAR ARRAY PROBES FOR ARTIS 3200 DIAG. ULTRA. | Philips Medical Systems (Cleveland), Inc. | 1988-06-01 |
| K880900 | SSD-620 LINEAR/CONVEX ARRAY SECTOR SCANNER | Corometrics Medical Systems, Inc. | 1988-06-01 |
| K862364 | NEEDLE GUIDE (FOR ULTRASOUND TRANSDUCERS) | Swemed Laboratories, Inc. | 1986-08-19 |
| K862627 | SONORANGER TRANSVAGINAL PROBE | Ausonics Pty , Ltd. | 1986-08-01 |
| K861931 | 645OB SECTOR/LINEAR ULTRASOUND SCANNER | Ge Medical Systems Information Technologies | 1986-07-31 |
| K860233 | 5 MHZ INTRACAVITARY PROBE, MODEL H4222V | General Electric Co. | 1986-06-02 |
| K853711 | 5.0 MHZ INTRACAVITARY SECTOR PROBE | General Electric Co. | 1985-12-18 |
| K853407 | INTRA VAGINAL TRANSDUCER | Advanced Technology Laboratories, Inc. | 1985-09-27 |
| K851902 | MODEL U-1000 ULTRASONIC SCANNER | Fukuda Denshi USA, Inc. | 1985-09-27 |
| K852439 | FETA SCAN 1000 OBSTETRICAL IMAGER | International Biomedics, Inc. | 1985-08-30 |
| K842261 | OB ULTRASOUND LINEAR SCANNER 630 | Ge Medical Systems Information Technologies | 1984-09-19 |
| K840623 | OBSTETRICAL ULTRASOUND COMPUTER | R & S Systems | 1984-05-11 |
| K834088 | GEL-SCAN DIAGNOSTIC ULTRASOUND COUPLING | Whs Products, Inc. | 1983-12-15 |
| K833488 | SONICOMP | Sonicaid, Inc. | 1983-11-28 |
| K811520 | GRAYLINE IMAGING SYSTEM | Sonics Research Corp. | 1981-07-02 |
| K810305 | DATASON DB ULTRASOUND IMAGING SYSTEM | General Electric Co. | 1981-03-13 |
| K780876 | ULTRASONIC IMAGER | Air-Shields, Inc. | 1978-06-27 |
| K771816 | ROCHE AXISCAN 5 | Roche Medical Electronics, Inc. | 1977-10-19 |
| K770644 | ULTRASOUND B-SCANNING SYSTEM | Unirad Corp. | 1977-04-14 |
| K760874 | V.I. OCTOSON ULTRASONIC SYSTEM | General Electric Co. | 1976-12-16 |
| K761052 | REAL TIME OBSTETRICAL ULTRASONIC SCANNER | Smithkline Diagnostics, Inc. | 1976-12-16 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 17350025911646 | Transducer Cover | Vitrolife Sweden AB | 2016-09-13 |
| 17350025911653 | Transducer Cover | Vitrolife Sweden AB | 2016-09-13 |
| 17350025911677 | Transducer Cover | Vitrolife Sweden AB | 2016-09-13 |