Biosound, Inc.
Medical device manufacturer in Indianapolis, IN.
39510(k) clearances
0PMA approvals
0recalls
Device types
- ITX Transducer, Ultrasonic, Diagnostic 13
- DXK Echocardiograph 5
- IYO System, Imaging, Pulsed Echo, Ultrasonic 4
- DPS Electrocardiograph 3
- GWQ Full-Montage Standard Electroencephalograph 3
- JOP Transducer, Ultrasonic 2
- LNH System, Nuclear Magnetic Resonance Imaging 2
- DPW Flowmeter, Blood, Cardiovascular 1
- IYN System, Imaging, Pulsed Doppler, Ultrasonic 1
- IKN Electromyograph, Diagnostic 1
- OLT Non-Normalizing Quantitative… 1
- GWF Stimulator, Electrical, Evoked Response 1
- LMB Device, Digital Image Storage, Radiological 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K971700 | Biopsy Accessory for Ultrasound TransducerITX · Traditional | 07/09/1997SE |
| K963936 | Accesspoint, Med E-Mail, Dicom ReaderLMB · Traditional | 03/31/1997SE |
| K963262 | Artoscan MLNH · Traditional | 03/28/1997SE |
| K963662 | Galileo Evoked PotentialreGWF · Traditional | 02/26/1997SE |
| K953716 | Intracavity TransducersITX · Traditional | 04/17/1996SE |
| K953530 | Diagnostic Ultrasound Tranducers P10A, P12A, PT10A, PA11-AIYO · Traditional | 04/08/1996SE |
| K953819 | Diagnostic Ultrasound TranducerITX · Traditional | 03/01/1996SE |
| K953759 | Diagnostic Ultrasound TransducerITX · Traditional | 03/01/1996SE |
| K955458 | Ultrasound Probe Biopsy AccessoriesITX · Traditional | 02/12/1996SE |
| K953579 | Tee ProbeITX · Traditional | 02/02/1996SE |
| K953430 | Ultrasound Probe Biopsy AccessoriesITX · Traditional | 10/24/1995SE |
| K941935 | LP-12 Laparoscopic ProbeITX · Traditional | 09/18/1995SE |
| K944287 | 7050 Ultrasound Imaging SystemITX · Traditional | 06/02/1995SE |
| K944485 | 4000 Au Ultrasound Imaging SystemIYO · Traditional | 05/24/1995SE |
| K934050 | Topographic Brain Mapping OptionOLT · Traditional | 02/03/1994SE |
| K931022 | ArtoscanLNH · Traditional | 10/07/1993SE |
| K922703 | The Acta FormulaDPS · Traditional | 04/27/1993SE |
| K923894 | Yhe Galileo Pleiade ElectroencephalographGWQ · Traditional | 03/10/1993SE |
| K922488 | Phasis ElectromyographIKN · Traditional | 03/02/1993SE |
| K923860 | The Galileo Line -- Planet 100, 200 & 300 & StarGWQ · Traditional | 02/04/1993SE |
| K923950 | The Galileo VEGA-24 ElectroencephalographGWQ · Traditional | 01/26/1993SE |
| K922291 | Personal 120/210 Laptop Stress OptionDPS · Traditional | 11/04/1992SE |
| K915860 | Linear Peripheralvascular Ultrsound ProbeITX · Traditional | 07/02/1992SE |
| K913209 | Accessory to Genesis III (GCFM)DXK · Traditional | 05/15/1992SE |
| K914006 | Biplane Transrectal ProbeITX · Traditional | 04/02/1992SE |
| K920364 | Electrocardiograph Stress Test Firmware ActavisDPS · Traditional | 03/17/1992SE |
| K912088 | Biopsy Accessories for Ultrasound ProbesITX · Traditional | 12/05/1991SE |
| K895645 | Biosound Phase 2 Diagnostic Ultrasound SystemIYO · Traditional | 03/06/1990SE |
| K894370 | Genesis III, (Mod. 7003/7004)DXK · Traditional | 01/29/1990SE |
| K894163 | Phase 2 Transcranial ProbeIYN · Traditional | 09/12/1989SE |
| K883238 | Genesis II Transcranial ProbeIYO · Traditional | 08/24/1988SE |
| K881723 | Genesis II 7.5MHZ Ultrasound TransducerJOP · Traditional | 08/12/1988SE |
| K871442 | Biosound Mmi UltrasoundJOP · Traditional | 05/20/1988SE |
| K873032 | Genesis II, 2.5/5.0 MHZ S.E/5.0MHZ/3.5 16/19 MM anDXK · Traditional | 02/18/1988SE |
| K870899 | Ezu-Pc 2A/5.0 & 3A/3.5MHZ, Eup-Cd 121/5.0 ConvexITX · Traditional | 12/30/1987SE |
| K871697 | Genesis IIDXK · Traditional | 11/06/1987SE |
| K862859 | Eub 151 Ultrasound System/Eub 150 UltrasoundDXK · Traditional | 02/02/1987SE |
| K862841 | High Velocity CW Doppler SystemDPW · Traditional | 11/10/1986SE |
| K837063 | Biosound Surgiscan, Ultrasound Imaging System · Traditional | 04/04/1983SE |