Imager, Ultrasonic Obstetric-Gynecologic
FDA product code HEM · Class II (moderate risk) · 21 CFR 884.2225 · Obstetrics/Gynecology
30510(k) clearances
0PMA approvals
1recalls
Manufacturers
- General Electric Co. 4
- Corometrics Medical Systems, Inc. 2
- Ge Medical Systems Information Technologies 2
- Advanced Technology Laboratories, Inc. 2
- International Biomedics, Inc. 1
- Solomon Technology Labs 1
- Digisonics, Inc 1
- Elscint, Inc. 1
- Siemens Medical Solutions USA, Inc. 1
- Philips Medical Systems (Cleveland) Inc 1
- Swemed Laboratories, Inc. 1
- Ausonics Pty , Ltd. 1
- Fukuda Denshi USA, Inc. 1
- R & S Systems 1
- Whs Products, Inc. 1
- Sonicaid, Inc. 1
- Sonics Research Corp. 1
- Air-Shields, Inc. 1
- Roche Medical Electronics, Inc. 1
- Unirad Corp. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K951393 | Abacus Ob Ultrasoung Computer SoftwareHEM · Traditional | Solomon Technology Labs | 05/01/1995SE |
| K942490 | Babe Computer Pogram for Obstetric UltrasoundHEM · Traditional | Medical Soft, Inc. | 02/15/1995SE |
| K910426 | Sdu 500 Diagnostic Ultrasound InstrumentHEM · Traditional | Shimadzu Medical Systems | 06/06/1991SE |
| K905000 | Aloka UST-964P-5 Endovaginal TransducerHEM · Traditional | Corometrics Medical Systems, Inc. | 01/31/1991SE |
| K900505 | Sonoace 88 Portable Ultrasound ScannerHEM · Traditional | Medison Co., Ltd. | 08/10/1990SE |
| K900271 | Model OB-500 Fetal Growth Analysis & Option OblinkHEM · Traditional | Digisonics, Inc. | 04/19/1990SE |
| K890637 | Extended Obstetrics Software Computation PackageHEM · Traditional | Elscint, Inc. | 06/12/1989SE |
| K881329 | Fetal Doppler for Ultramark 4 and 8HEM · Traditional | Advanced Technology Laboratories, Inc. | 04/14/1989SE |
| K885061 | Siemens Intravaginal TransducerHEM · Traditional | Siemens Medical Solutions USA, Inc. | 02/23/1989SE |
| K881185 | Annular Array Probes for Artis 3200 Diag. Ultra.HEM · Traditional | Philips Medical Systems (Cleveland), Inc. | 06/01/1988SE |
| K880900 | SSD-620 Linear/Convex Array Sector ScannerHEM · Traditional | Corometrics Medical Systems, Inc. | 06/01/1988SE |
| K862364 | Needle Guide (for Ultrasound Transducers)HEM · Traditional | Swemed Laboratories, Inc. | 08/19/1986SN |
| K862627 | Sonoranger Transvaginal ProbeHEM · Traditional | Ausonics Pty , Ltd. | 08/01/1986SN |
| K861931 | 645OB Sector/Linear Ultrasound ScannerHEM · Traditional | Ge Medical Systems Information Technologies | 07/31/1986SN |
| K860233 | 5 MHZ Intracavitary Probe, Model H4222VHEM · Traditional | General Electric Co. | 06/02/1986SE |
| K853711 | 5.0 MHZ Intracavitary Sector ProbeHEM · Traditional | General Electric Co. | 12/18/1985SE |
| K853407 | Intra Vaginal TransducerHEM · Traditional | Advanced Technology Laboratories, Inc. | 09/27/1985SE |
| K851902 | Model U-1000 Ultrasonic ScannerHEM · Traditional | Fukuda Denshi USA, Inc. | 09/27/1985SE |
| K852439 | Feta Scan 1000 Obstetrical ImagerHEM · Traditional | International Biomedics, Inc. | 08/30/1985SE |
| K842261 | Ob Ultrasound Linear Scanner 630HEM · Traditional | Ge Medical Systems Information Technologies | 09/19/1984SE |
| K840623 | Obstetrical Ultrasound ComputerHEM · Traditional | R & S Systems | 05/11/1984SE |
| K834088 | Gel-Scan Diagnostic Ultrasound CouplingHEM · Traditional | Whs Products, Inc. | 12/15/1983SE |
| K833488 | SonicompHEM · Traditional | Sonicaid, Inc. | 11/28/1983SE |
| K811520 | Grayline Imaging SystemHEM · Traditional | Sonics Research Corp. | 07/02/1981SE |
| K810305 | Datason DB Ultrasound Imaging SystemHEM · Traditional | General Electric Co. | 03/13/1981SE |
| K780876 | Ultrasonic ImagerHEM · Traditional | Air-Shields, Inc. | 06/27/1978SE |
| K771816 | Roche Axiscan 5HEM · Traditional | Roche Medical Electronics, Inc. | 10/19/1977SE |
| K770644 | Ultrasound B-Scanning SystemHEM · Traditional | Unirad Corp. | 04/14/1977SE |
| K761052 | Real Time Obstetrical Ultrasonic ScannerHEM · Traditional | Smithkline Diagnostics, Inc. | 12/16/1976SE |
| K760874 | V.I. Octoson Ultrasonic SystemHEM · Traditional | General Electric Co. | 12/16/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2066-2011 | OB-Link release 2.0.7. distributed by Digisonics, Inc., 3701 Kirby Drive, Houston TX…Data/measurements from a OB report sent from ultrasound systems populated the wrong OB-View report | Digisonics, Inc | 05/12/2008Terminated |