Profile 2000 Mammography System, PRO-2000
FDA 510(k) K984092 · Trex Medical Corp.
510(k) numberK984092
Submission
- Device name
- Profile 2000 Mammography System, PRO-2000
- Applicant
- Trex Medical Corp.
Copiague, NY, US - Received
- November 16, 1998
- Decision date
- February 5, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Profile 2000 Mammography System, PRO-2000 cleared by the FDA?
Profile 2000 Mammography System, PRO-2000 (K984092) received a 510(k) decision of Substantially Equivalent on February 5, 1999, 81 days after the submission was received.
What is the product code of K984092?
The FDA product code is IZH – System, X-Ray, Mammographic, a Class II (moderate risk) device regulated under 21 CFR 892.1710.