Affirm Lateral Arm Upright Biopsy Accessory
FDA 510(k) K161575 · Hologic
510(k) numberK161575
Submission
- Device name
- Affirm Lateral Arm Upright Biopsy Accessory
- Applicant
- Hologic
Danbury, CT, US - Received
- June 7, 2016
- Decision date
- August 10, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K161920 | Comfort CoverIZH · Traditional | Precision Dynamics Corporation | 07/15/2016SE |
| K153486 | Affirm Prone Biopsy SystemIZH · Traditional | Hologic, Inc. | 04/01/2016SE |
| K152038 | MammoGRIPIZH · Traditional | Women'S Imaging Solutions Enterprises, LLC | 12/22/2015SE |
| K123414 | Specboard Jr.IZH · Traditional | Macbrud Corp., Medical Division | 01/11/2013SE |
| K122836 | Affirm Breast Biopsy Guidance SystemIZH · Special | Lorad, A Hologic Co. | 01/11/2013SE |
| K113607 | Biopsy Digit S Biopsy SLIZH · Traditional | Giotto USA, LLC | 08/10/2012SE |
| K113284 | Biopsy PositionerIZH · Traditional | Fuji Film Medical Systems | 03/07/2012SE |
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Questions and answers
When was Affirm Lateral Arm Upright Biopsy Accessory cleared by the FDA?
Affirm Lateral Arm Upright Biopsy Accessory (K161575) received a 510(k) decision of Substantially Equivalent on August 10, 2016, 64 days after the submission was received.
What is the product code of K161575?
The FDA product code is IZH – System, X-Ray, Mammographic, a Class II (moderate risk) device regulated under 21 CFR 892.1710.