Trident Specimen Radiography System, Model : RC TRI-00001
FDA 510(k) K111508 · Hologic, Inc.
510(k) numberK111508
Submission
- Device name
- Trident Specimen Radiography System, Model : RC TRI-00001
- Applicant
- Hologic, Inc.
Bedford, MA, US - Received
- June 1, 2011
- Decision date
- August 19, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Trident Specimen Radiography System, Model : RC TRI-00001 cleared by the FDA?
Trident Specimen Radiography System, Model : RC TRI-00001 (K111508) received a 510(k) decision of Substantially Equivalent on August 19, 2011, 79 days after the submission was received.
What is the product code of K111508?
The FDA product code is MWP – Cabinet, X-Ray System, a Class II (moderate risk) device regulated under 21 CFR 892.1680.