B-Scan Opthalmic Ultrasound Imaging System
FDA 510(k) K926251 · Biovision, Inc.
510(k) numberK926251
Submission
- Device name
- B-Scan Opthalmic Ultrasound Imaging System
- Applicant
- Biovision, Inc.
France, FR - Received
- December 14, 1992
- Decision date
- September 14, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was B-Scan Opthalmic Ultrasound Imaging System cleared by the FDA?
B-Scan Opthalmic Ultrasound Imaging System (K926251) received a 510(k) decision of Substantially Equivalent on September 14, 1993, 274 days after the submission was received.
What is the product code of K926251?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.