LUMINOS AGILE
System, X-ray, Fluoroscopic, Image-intensified
SIEMENS MEDICAL SOLUTIONS USA, INC.
The following data is part of a premarket notification filed by Siemens Medical Solutions Usa, Inc. with the FDA for Luminos Agile.
Pre-market Notification Details
| Device ID | K111292 |
| 510k Number | K111292 |
| Device Name: | LUMINOS AGILE |
| Classification | System, X-ray, Fluoroscopic, Image-intensified |
| Applicant | SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. Malvern, PA 19355 -1406 |
| Contact | Patricia D Jones |
| Correspondent | Patricia D Jones SIEMENS MEDICAL SOLUTIONS USA, INC. 51 VALLEY STREAM PKWY. Malvern, PA 19355 -1406 |
| Product Code | JAA |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-06 |
| Decision Date | 2011-06-03 |
| Summary: | summary |
Trademark Results [LUMINOS AGILE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LUMINOS AGILE 79096890 4072619 Live/Registered |
Siemens Healthcare GmbH 2011-03-07 |
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