Biosound Surgiscan, Ultrasound Imaging System
FDA 510(k) K837063 · Biosound, Inc.
510(k) numberK837063
Submission
- Device name
- Biosound Surgiscan, Ultrasound Imaging System
- Applicant
- Biosound, Inc.
Indianapolis, IN, US - Received
- January 17, 1983
- Decision date
- April 4, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
No product code recorded.
More from Biosound, Inc.
| 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 |
Questions and answers
When was Biosound Surgiscan, Ultrasound Imaging System cleared by the FDA?
Biosound Surgiscan, Ultrasound Imaging System (K837063) received a 510(k) decision of Substantially Equivalent on April 4, 1983, 77 days after the submission was received.