Mammopath
FDA 510(k) K021113 · Fischer Imaging Corp.
510(k) numberK021113
Submission
- Device name
- Mammopath
- Applicant
- Fischer Imaging Corp.
Denver, CO, US - Received
- April 5, 2002
- Decision date
- June 13, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K230136 | TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US)MWP · Traditional | Compai Healthcare (Suzhou) Co.,Ltd | 04/24/2023SE |
| K213691 | Solas ORMWP · Traditional | Cirdan Imaging, Ltd. | 12/22/2021SE |
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| K210956 | Kubtec Mozart (XPERT42)MWP · Special | Kub Technologies, Inc. | 08/31/2021SE |
| K202713 | TrueView 100 ProMWP · Traditional | Compai Healthcare (Shenzhen) Co.,Ltd | 11/18/2020SE |
| K200756 | Kubtec Mozart SupraMWP · Traditional | Kub Technologies, Inc. | 06/12/2020SE |
| K192939 | Volumetric Specimen ImagerMWP · Traditional | Clarix Imaging | 12/27/2019SE |
| K193317 | CoreLite X-Ray Specimen CabinetMWP · Traditional | Cirdan Imaging Limited | 12/13/2019SE |
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| 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 |
| K945619 | Athena HFXIZH · 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 Mammopath cleared by the FDA?
Mammopath (K021113) received a 510(k) decision of Substantially Equivalent on June 13, 2002, 69 days after the submission was received.
What is the product code of K021113?
The FDA product code is MWP – Cabinet, X-Ray System, a Class II (moderate risk) device regulated under 21 CFR 892.1680.