DICOM Viewer
by Brainlab AG
510(k) K153653
DICOM Viewer is a medical device (FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by Brainlab AG, cleared under FDA 510(k) K153653 on 13 Apr 2016, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK153653 | Date13 Apr 2016 | StatusActive |
Official records
- FDA 510(k) database K153653
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LLZ
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K153653
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| DICOM VIEWER 3.2 – INSTALLER | 26206-02 / 3.2 | 04056481007102 | No longer on the market | |
| Viewer 4.0 | 4.0 | 04056481139070 | No longer on the market |
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