Advantage
FDA 510(k) K883860 · Fischer Imaging Corp.
510(k) numberK883860
Submission
- Device name
- Advantage
- Applicant
- Fischer Imaging Corp.
Denver, CO, US - Received
- September 13, 1988
- Decision date
- November 21, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K961207 | Ep-X BiplaneJAA · Traditional | 08/20/1996SE |
| K961022 | Tangent Vi TableIXR · Traditional | 05/03/1996SE |
| K950291 | Digital 625HFIZO · Traditional | 03/23/1995SE |
| K945619 | Athena HFXIZH · Traditional | 03/23/1995SE |
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Questions and answers
When was Advantage cleared by the FDA?
Advantage (K883860) received a 510(k) decision of Substantially Equivalent on November 21, 1988, 69 days after the submission was received.
What is the product code of K883860?
The FDA product code is IZI – System, X-Ray, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1600.