Biolucent Mammography Cushion
FDA 510(k) K003795 · Biolucent, Inc.
510(k) numberK003795
Submission
- Device name
- Biolucent Mammography Cushion
- Applicant
- Biolucent, Inc.
Aliso Viejo, CA, US - Received
- December 8, 2000
- Decision date
- February 14, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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More from Giotto USA, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K070659 | Biolucent Applicator KitJAQ · Special | 04/04/2007SESU |
| K062830 | Biolucent Applicator KitJAQ · Special | 10/20/2006SE |
| K062141 | Mammopad Radiolucent CushionIYX · Traditional | 09/13/2006SE |
| K061241 | Biolucent Applicator, Model Rta-XxJAQ · Traditional | 07/28/2006SE |
| K053595 | Curay Custom Seed ArrayKXK · Traditional | 02/28/2006SE |
Questions and answers
When was Biolucent Mammography Cushion cleared by the FDA?
Biolucent Mammography Cushion (K003795) received a 510(k) decision of Substantially Equivalent on February 14, 2001, 68 days after the submission was received.
What is the product code of K003795?
The FDA product code is IZH – System, X-Ray, Mammographic, a Class II (moderate risk) device regulated under 21 CFR 892.1710.