Siemens Pacs/I-A
FDA 510(k) K880690 · Siemens Gammasonics, Inc.
510(k) numberK880690
Submission
- Device name
- Siemens Pacs/I-A
- Applicant
- Siemens Gammasonics, Inc.
Des Plaines, IL, US - Received
- February 22, 1988
- Decision date
- October 31, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K922372 | Multispect(Tm) 3 Triple Detector Camera SystemKPS · Traditional | 08/17/1992SE |
| K920310 | Sienet Archive Server, Isa I, Isa II Storage ServeLMD · Traditional | 03/30/1992SE |
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| K914313 | HicorIZI · Traditional | 11/27/1991SE |
Questions and answers
When was Siemens Pacs/I-A cleared by the FDA?
Siemens Pacs/I-A (K880690) received a 510(k) decision of Substantially Equivalent on October 31, 1988, 252 days after the submission was received.
What is the product code of K880690?
The FDA product code is IZI – System, X-Ray, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1600.