Hologic Cer 20/20, Computed Equal Radio Diag Chest
FDA 510(k) K913757 · Hologic, Inc.
510(k) numberK913757
Submission
- Device name
- Hologic Cer 20/20, Computed Equal Radio Diag Chest
- Applicant
- Hologic, Inc.
Waltham, MA, US - Received
- August 21, 1991
- Decision date
- October 30, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Hologic Cer 20/20, Computed Equal Radio Diag Chest cleared by the FDA?
Hologic Cer 20/20, Computed Equal Radio Diag Chest (K913757) received a 510(k) decision of Substantially Equivalent on October 30, 1991, 70 days after the submission was received.
What is the product code of K913757?
The FDA product code is KPR – System, X-Ray, Stationary, a Class II (moderate risk) device regulated under 21 CFR 892.1680.