Biopsy Accessory for Ultrasound Transducer
FDA 510(k) K971700 · Biosound, Inc.
510(k) numberK971700
Submission
- Device name
- Biopsy Accessory for Ultrasound Transducer
- Applicant
- Biosound, Inc.
Indianapolis, IN, US - Received
- May 8, 1997
- Decision date
- July 9, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K250469 | Accuro® 3S Needle Guide KitITX · Traditional | Rivanna Medical, Inc. | 06/13/2025SE |
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More from Vitrolife Sweden AB
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| 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 |
Questions and answers
When was Biopsy Accessory for Ultrasound Transducer cleared by the FDA?
Biopsy Accessory for Ultrasound Transducer (K971700) received a 510(k) decision of Substantially Equivalent on July 9, 1997, 62 days after the submission was received.
What is the product code of K971700?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.