Athena HFX
FDA 510(k) K945619 · Fischer Imaging Corp.
510(k) numberK945619
Submission
- Device name
- Athena HFX
- Applicant
- Fischer Imaging Corp.
Denver, CO, US - Received
- November 15, 1994
- Decision date
- March 23, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code IZH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K203509 | Smart FinderIZH · Special | Ims Giotto S.P.A. | 07/14/2021SE |
| K202294 | Affirm Contrast BiopsyIZH · Special | Hologic, Inc. | 10/05/2020SE |
| K191495 | Biopsy PositionerIZH · Special | Fujifilm Corporation | 07/03/2019SE |
| K161575 | Affirm Lateral Arm Upright Biopsy AccessoryIZH · Traditional | Hologic | 08/10/2016SE |
| 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 |
More from Giotto USA, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K042095 | MammotestIZH · Traditional | 10/29/2004SE |
| K021113 | MammopathMWP · Traditional | 06/13/2002SE |
| K981414 | LC PositionerJAA · Traditional | 07/16/1998SE |
| K973400 | Mammotest Adapter DriverIZH · Traditional | 11/10/1997SE |
| K964806 | MD-1835IXL · Traditional | 03/04/1997SE |
| K961207 | Ep-X BiplaneJAA · Traditional | 08/20/1996SE |
| K961022 | Tangent Vi TableIXR · Traditional | 05/03/1996SE |
| K950291 | Digital 625HFIZO · Traditional | 03/23/1995SE |
| K944150 | Micro X-65 HFIZO · Traditional | 09/16/1994SE |
| K944149 | Micro X-80 HFIZO · Traditional | 09/16/1994SE |
Questions and answers
When was Athena HFX cleared by the FDA?
Athena HFX (K945619) received a 510(k) decision of Substantially Equivalent on March 23, 1995, 128 days after the submission was received.
What is the product code of K945619?
The FDA product code is IZH – System, X-Ray, Mammographic, a Class II (moderate risk) device regulated under 21 CFR 892.1710.