Zonograph 6
FDA 510(k) K810307 · Siemens Corp.
510(k) numberK810307
Submission
- Device name
- Zonograph 6
- Applicant
- Siemens Corp.
Mchenry, IL, US - Received
- February 5, 1981
- Decision date
- March 11, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code IZF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252649 | TAP2DIZF · Traditional | Nano-X Imaging , Ltd. | 02/02/2026SE |
| K252133 | Adaptix Ortho350IZF · Traditional | Adaptix Limited | 11/06/2025SE |
| K250850 | Nanox.ARC XIZF · Traditional | Nano-X Imaging , Ltd. | 04/16/2025SE |
| K242395 | Nanox.ARCIZF · Traditional | Nano-X Imaging , Ltd. | 12/04/2024SE |
| K222934 | Nanox.ARCIZF · Traditional | Nano-X Imaging , Ltd. | 04/28/2023SE |
| K221949 | Ortho Device, ADAPTIX 3D Orthopedic Imaging SystemIZF · Traditional | Pausch Medical GmbH | 01/26/2023SE |
| K213081 | CLISIS SYSTEMS, Discovery RF180IZF · Traditional | General Medical Merate S.P.A | 10/26/2021SE |
| K193262 | DR 600 with TomosynthesisIZF · Traditional | Agfa N.V. | 03/09/2020SE |
| K183275 | DR 800 with TomosynthesisIZF · Traditional | Agfa N.V. | 02/01/2019SE |
| K132261 | Discovery XR656 with Volumerad (Digital Tomosynthesis)IZF · Traditional | Ge Medical Systems, LLC | 11/18/2013SE |
More from Ge Medical Systems, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K150843 | syngo®.via (version VB10A)LLZ · Abbreviated | 04/24/2015SE |
| K123375 | Syngo.ViaLLZ · Traditional | 11/20/2012SE |
| K110366 | Syngo.Ct Cardiac FunctionJAK · Traditional | 04/12/2011SE |
| K103360 | Dimension Vista Digitoxin Calibrator - DGTX CalJIT · Traditional | 12/17/2010SE |
| K081182 | Microscan Dried Gram-Positive Mic/Combo Panels New Antimicrobial Test - Inducible…JWY · Traditional | 08/08/2008SE |
| K071310 | Syngo CT Oncology Software PackageJAK · Traditional | 06/08/2007SE |
| K063507 | Syngo Neuro PBV CTJAK · Traditional | 11/30/2006SE |
| K063373 | Flex Loop Coil Set 3TMOS · Traditional | 11/17/2006SE |
| K053024 | Syngo Neuro Dsa CTJAK · Traditional | 11/04/2005SE |
| K050867 | Syngo Body Perfusion-CtJAK · Traditional | 04/14/2005SE |
Questions and answers
When was Zonograph 6 cleared by the FDA?
Zonograph 6 (K810307) received a 510(k) decision of Substantially Equivalent on March 11, 1981, 34 days after the submission was received.
What is the product code of K810307?
The FDA product code is IZF – System, X-Ray, Tomographic, a Class II (moderate risk) device regulated under 21 CFR 892.1740.