Mammography X-Ray Equipment Models MGF101 and MGF110, Alpha III, Alpha ST, Alpha RT and Alpha Iq
FDA 510(k) K981641 · Instrumentarium Corp.
510(k) numberK981641
Submission
- Device name
- Mammography X-Ray Equipment Models MGF101 and MGF110, Alpha III, Alpha ST, Alpha RT and Alpha Iq
- Applicant
- Instrumentarium Corp.
Milwaukee, WI, US - Received
- May 8, 1998
- Decision date
- July 17, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Mammography X-Ray Equipment Models MGF101 and MGF110, Alpha III, Alpha ST, Alpha RT and Alpha Iq cleared by the FDA?
Mammography X-Ray Equipment Models MGF101 and MGF110, Alpha III, Alpha ST, Alpha RT and Alpha Iq (K981641) received a 510(k) decision of Substantially Equivalent on July 17, 1998, 70 days after the submission was received.
What is the product code of K981641?
The FDA product code is IZH – System, X-Ray, Mammographic, a Class II (moderate risk) device regulated under 21 CFR 892.1710.