Planmed Sophie & Planned Sophie Classic
FDA 510(k) K983659 · Planmed OY
510(k) numberK983659
Submission
- Device name
- Planmed Sophie & Planned Sophie Classic
- Applicant
- Planmed OY
Helsinki, FI - Received
- October 19, 1998
- Decision date
- November 16, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) statement available from FDA
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| 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 |
|---|---|---|
| K250318 | Planmed XFISFV · Traditional | 09/26/2025SE |
| K211720 | Planmed Clarity 2D, Planmed Clarify SMUE · Traditional | 07/18/2022SE |
| K213278 | Planmed VerityOAS · Traditional | 04/28/2022SE |
| K192317 | Planmed Clarity 2D and Clarity SMUE · Traditional | 10/23/2020SE |
| K180918 | Planmed VerityOAS · Traditional | 11/30/2018SE |
| K163328 | Planmed ClarityMUE · Traditional | 12/28/2017SE |
| K143435 | Planmed VerityOAS · Traditional | 05/14/2015SE |
| K121418 | Planmed VerityJAK · Traditional | 02/01/2013SE |
| K121963 | Planmed Nuance DigiguideMUE · Traditional | 11/21/2012SE |
| K042671 | Planmed Sophie Nuance ClassicIZH · Traditional | 11/19/2004SE |
Questions and answers
When was Planmed Sophie & Planned Sophie Classic cleared by the FDA?
Planmed Sophie & Planned Sophie Classic (K983659) received a 510(k) decision of Substantially Equivalent on November 16, 1998, 28 days after the submission was received.
What is the product code of K983659?
The FDA product code is IZH – System, X-Ray, Mammographic, a Class II (moderate risk) device regulated under 21 CFR 892.1710.