Planmed Cytoguide
FDA 510(k) K973493 · Planmed OY
510(k) numberK973493
Submission
- Device name
- Planmed Cytoguide
- Applicant
- Planmed OY
Wood Dale, IL, US - Received
- September 15, 1997
- Decision date
- November 10, 1997
- 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 |
|---|---|---|
| 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 Cytoguide cleared by the FDA?
Planmed Cytoguide (K973493) received a 510(k) decision of Substantially Equivalent on November 10, 1997, 56 days after the submission was received.
What is the product code of K973493?
The FDA product code is IZH – System, X-Ray, Mammographic, a Class II (moderate risk) device regulated under 21 CFR 892.1710.