Ai 5200 Diagnostic Ultrasound System
FDA 510(k) K880839 · Phoenix Imaging
510(k) numberK880839
Submission
- Device name
- Ai 5200 Diagnostic Ultrasound System
- Applicant
- Phoenix Imaging
Tempe, AZ, US - Received
- March 1, 1988
- Decision date
- June 10, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K250331 | Astrasono A3Pro Bladder Scanner (A3Pro)IYO · Traditional | Astrasono Technology Co., Ltd. | 09/30/2025SE |
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| K243227 | B-ScanIYO · Traditional | Accutome, Inc. Doing Business AS Keeler USA | 07/11/2025SE |
More from Accutome, Inc. Doing Business AS Keeler USA
| 510(k) | Device | Decision |
|---|---|---|
| K883845 | Resubmitted Ai 5200 Ultrasound TransducerDXK · Traditional | 02/03/1989SE |
Questions and answers
When was Ai 5200 Diagnostic Ultrasound System cleared by the FDA?
Ai 5200 Diagnostic Ultrasound System (K880839) received a 510(k) decision of Substantially Equivalent on June 10, 1988, 101 days after the submission was received.
What is the product code of K880839?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.