Minxray 500M Mammographic System
FDA 510(k) K854510 · Minxray, Inc.
510(k) numberK854510
Submission
- Device name
- Minxray 500M Mammographic System
- Applicant
- Minxray, Inc.
Evanston, IL, US - Received
- November 12, 1985
- Decision date
- January 1, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K210479 | IMPACT and X-RangerIZL · Special | 03/19/2021SE |
| K201575 | CMDR 2C (Multiple Models)IZL · Special | 07/08/2020SE |
| K191451 | CMDR 2CW (Multiple models)IZL · Special | 07/03/2019SE |
| K182207 | TR90BHIZL · Traditional | 12/14/2018SE |
| K171353 | CMDR 2ST (Multiple Models), CMDR 2SPE (Multiple Models), IntegrisIZL · Special | 06/07/2017SE |
| K153059 | HF1202H PowerPlus Portable X-ray EquipmentIZL · Special | 02/02/2016SE |
| K141885 | CMDR-2ST & CMDR-2SLWT Digital Portable X-RayIZL · Special | 09/18/2014SE |
| K091255 | Minxray, Model: BPD60EHD · Traditional | 05/12/2010SE |
| K100449 | Minxray Model CMDR-2SIZL · Traditional | 04/23/2010SE |
| K082627 | Minxray, Model CMDR-1S and CMDR-1S-MILIZL · Traditional | 11/07/2008SE |
Questions and answers
When was Minxray 500M Mammographic System cleared by the FDA?
Minxray 500M Mammographic System (K854510) received a 510(k) decision of Substantially Equivalent on January 1, 1986, 50 days after the submission was received.
What is the product code of K854510?
The FDA product code is IZH – System, X-Ray, Mammographic, a Class II (moderate risk) device regulated under 21 CFR 892.1710.