Biosound, Inc.
Indianapolis, IN, US
Biosound, Inc. appears in FDA device records in Indianapolis, IN. FDA records list 39 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 39
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 39 510(k) clearances for Biosound, Inc. between 1983 and 1997. The busiest year on record is 1993, with 6. The most recent is 1997, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1983 | 1 |
| 1986 | 1 |
| 1987 | 3 |
| 1988 | 4 |
| 1989 | 1 |
| 1990 | 2 |
| 1991 | 1 |
| 1992 | 5 |
| 1993 | 6 |
| 1994 | 1 |
| 1995 | 4 |
| 1996 | 6 |
| 1997 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K971700 | BIOPSY ACCESSORY FOR ULTRASOUND TRANSDUCER | ITX | Substantially Equivalent | |
| K963936 | ACCESSPOINT, MED E-MAIL, DICOM READER | LMB | Substantially Equivalent | |
| K963262 | ARTOSCAN M | LNH | Substantially Equivalent | |
| K963662 | GALILEO EVOKED POTENTIALRE | GWF | Substantially Equivalent | |
| K953716 | INTRACAVITY TRANSDUCERS | ITX | Substantially Equivalent | |
| K953530 | DIAGNOSTIC ULTRASOUND TRANDUCERS P10A, P12A, PT10A, PA11-A | IYO | Substantially Equivalent | |
| K953819 | DIAGNOSTIC ULTRASOUND TRANDUCER | ITX | Substantially Equivalent | |
| K953759 | DIAGNOSTIC ULTRASOUND TRANSDUCER | ITX | Substantially Equivalent | |
| K955458 | ULTRASOUND PROBE BIOPSY ACCESSORIES | ITX | Substantially Equivalent | |
| K953579 | TEE PROBE | ITX | Substantially Equivalent | |
| K953430 | ULTRASOUND PROBE BIOPSY ACCESSORIES | ITX | Substantially Equivalent | |
| K941935 | LP-12 LAPAROSCOPIC PROBE | ITX | Substantially Equivalent | |
| K944287 | 7050 ULTRASOUND IMAGING SYSTEM | ITX | Substantially Equivalent | |
| K944485 | 4000 AU ULTRASOUND IMAGING SYSTEM | IYO | Substantially Equivalent | |
| K934050 | TOPOGRAPHIC BRAIN MAPPING OPTION | OLT | Substantially Equivalent | |
| K931022 | ARTOSCAN | LNH | Substantially Equivalent | |
| K922703 | THE ACTA FORMULA | DPS | Substantially Equivalent | |
| K923894 | YHE GALILEO PLEIADE ELECTROENCEPHALOGRAPH | GWQ | Substantially Equivalent | |
| K922488 | PHASIS ELECTROMYOGRAPH | IKN | Substantially Equivalent | |
| K923860 | THE GALILEO LINE -- PLANET 100, 200 & 300 & STAR | GWQ | Substantially Equivalent | |
| K923950 | THE GALILEO VEGA-24 ELECTROENCEPHALOGRAPH | GWQ | Substantially Equivalent | |
| K922291 | PERSONAL 120/210 LAPTOP STRESS OPTION | DPS | Substantially Equivalent | |
| K915860 | LINEAR PERIPHERALVASCULAR ULTRSOUND PROBE | ITX | Substantially Equivalent | |
| K913209 | ACCESSORY TO GENESIS III (GCFM) | DXK | Substantially Equivalent | |
| K914006 | BIPLANE TRANSRECTAL PROBE | ITX | Substantially Equivalent | |
| K920364 | ELECTROCARDIOGRAPH STRESS TEST FIRMWARE ACTAVIS | DPS | Substantially Equivalent | |
| K912088 | BIOPSY ACCESSORIES FOR ULTRASOUND PROBES | ITX | Substantially Equivalent | |
| K895645 | BIOSOUND PHASE 2 DIAGNOSTIC ULTRASOUND SYSTEM | IYO | Substantially Equivalent | |
| K894370 | GENESIS III, (MOD. 7003/7004) | DXK | Substantially Equivalent | |
| K894163 | PHASE 2 TRANSCRANIAL PROBE | IYN | Substantially Equivalent | |
| K883238 | GENESIS II TRANSCRANIAL PROBE | IYO | Substantially Equivalent | |
| K881723 | GENESIS II 7.5MHZ ULTRASOUND TRANSDUCER | JOP | Substantially Equivalent | |
| K871442 | BIOSOUND MMI ULTRASOUND | JOP | Substantially Equivalent | |
| K873032 | GENESIS II, 2.5/5.0 MHZ S.E/5.0MHZ/3.5 16/19 MM AN | DXK | Substantially Equivalent | |
| K870899 | EZU-PC 2A/5.0 & 3A/3.5MHZ, EUP-CD 121/5.0 CONVEX | ITX | Substantially Equivalent | |
| K871697 | GENESIS II | DXK | Substantially Equivalent | |
| K862859 | EUB 151 ULTRASOUND SYSTEM/EUB 150 ULTRASOUND | DXK | Substantially Equivalent | |
| K862841 | HIGH VELOCITY CW DOPPLER SYSTEM | DPW | Substantially Equivalent | |
| K837063 | BIOSOUND SURGISCAN, ULTRASOUND IMAGING SYSTEM | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- LMBDevice, Digital Image Storage, Radiological
- DXKEchocardiograph
- DPSElectrocardiograph
- IKNElectromyograph, Diagnostic
- DPWFlowmeter, Blood, Cardiovascular
- GWQFull-Montage Standard Electroencephalograph
- OLTNon-Normalizing Quantitative Electroencephalograph Software
- GWFStimulator, Electrical, Evoked Response
- IYNSystem, Imaging, Pulsed Doppler, Ultrasonic
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic
- LNHSystem, Nuclear Magnetic Resonance Imaging
- JOPTransducer, Ultrasonic
- ITXTransducer, Ultrasonic, Diagnostic
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain