Artoscan
FDA 510(k) K931022 · Biosound, Inc.
510(k) numberK931022
Submission
- Device name
- Artoscan
- Applicant
- Biosound, Inc.
Indianapolis, IN, US - Received
- March 1, 1993
- Decision date
- October 7, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| 510(k) | Device | Decision |
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| K971700 | Biopsy Accessory for Ultrasound TransducerITX · Traditional | 07/09/1997SE |
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| 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 Artoscan cleared by the FDA?
Artoscan (K931022) received a 510(k) decision of Substantially Equivalent on October 7, 1993, 220 days after the submission was received.
What is the product code of K931022?
The FDA product code is LNH – System, Nuclear Magnetic Resonance Imaging, a Class II (moderate risk) device regulated under 21 CFR 892.1000.