R2 Digitalnow Hd(Digitalnow HD)
FDA 510(k) K091368 · Hologic, Inc.
510(k) numberK091368
Submission
- Device name
- R2 Digitalnow Hd(Digitalnow HD)
- Applicant
- Hologic, Inc.
Bedford, MA, US - Received
- May 8, 2009
- Decision date
- June 4, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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Questions and answers
When was R2 Digitalnow Hd(Digitalnow HD) cleared by the FDA?
R2 Digitalnow Hd(Digitalnow HD) (K091368) received a 510(k) decision of Substantially Equivalent on June 4, 2009, 27 days after the submission was received.
What is the product code of K091368?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.