Radianalyzer Xpress
FDA 510(k) K092105 · Radi Medical Systems AB
510(k) numberK092105
Submission
- Device name
- Radianalyzer Xpress
- Applicant
- Radi Medical Systems AB
Uppsala, SE - Received
- July 14, 2009
- Decision date
- October 9, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQK – Computer, Diagnostic, Programmable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1425
- Specialty
- Cardiovascular
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| K123984 | Quantien Measurement SystemDQK · Special | 03/28/2013SE |
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| K062769 | Pressurewire Certus, Models 12006 and 12306DXO · Special | 12/04/2006SE |
| K042628 | Modification to: Radianalyzer, Model 12711DQK · Traditional | 01/19/2005SE |
| K033291 | Topseal Hemostatic Dressing, Model 11150QSY · Traditional | 03/17/2004SE |
| K031662 | Pressure Wire Sensor, Models 12004/12304DXO · Special | 06/06/2003SE |
| K024107 | Femostop Femoral Compression SystemDXC · Special | 12/24/2002SE |
| K022188 | Radianalyzer, Model 12710DQK · Traditional | 10/03/2002SE |
| K022187 | Pressure Wire Sensor, Models 12003/12303, 12004/12304DXO · Traditional | 09/24/2002SE |
Questions and answers
When was Radianalyzer Xpress cleared by the FDA?
Radianalyzer Xpress (K092105) received a 510(k) decision of Substantially Equivalent on October 9, 2009, 87 days after the submission was received.
What is the product code of K092105?
The FDA product code is DQK – Computer, Diagnostic, Programmable, a Class II (moderate risk) device regulated under 21 CFR 870.1425.