Radiography 7000 M
FDA 510(k) K233678 · Philips Medical Systems Dmc GmbH
510(k) numberK233678
Submission
- Device name
- Radiography 7000 M
- Applicant
- Philips Medical Systems Dmc GmbH
Hamburg, DE - Received
- November 16, 2023
- Decision date
- February 14, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K212837 | ProxiDiagnost N90JAA · Special | 09/21/2021SE |
| K210692 | DigitalDiagnostKPR · Special | 04/02/2021SE |
| K203087 | CombiDiagnost R90JAA · Traditional | 12/03/2020SE |
| K202564 | DigitalDiagnost C90MQB · Special | 09/30/2020SE |
| K182973 | DigitalDiagnost C90MQB · Traditional | 01/11/2019SE |
| K173433 | ProxiDiagnost N90OWB · Traditional | 02/05/2018SE |
Questions and answers
When was Radiography 7000 M cleared by the FDA?
Radiography 7000 M (K233678) received a 510(k) decision of Substantially Equivalent on February 14, 2024, 90 days after the submission was received.
What is the product code of K233678?
The FDA product code is IZL – System, X-Ray, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1720.