Digital Lightbox
510(k) K080608
Digital Lightbox is a medical device (FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by Brainlab AG, cleared under FDA 510(k) K080608 on 17 Apr 2008, 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 | NumberK080608 | Date17 Apr 2008 | StatusActive |
Official records
- FDA 510(k) database K080608
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- Withdrawn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
Similar devices
Other devices filed under FDA product code LLZ (System, Image Processing, Radiological).
- Arthrex OrthoVis Preoperative Plan by CUSTOM ORTHOPAEDIC SOLUTIONS, INC.
- nordicMEDiVA by Nordicneurolab AS
- I-DIXEL by J. MORITA U.S.A., INC
- ECHOCONNEX COMMUNICATOR by Connexmd
- SYNGO, BREAST CARE by SIEMENS MEDICAL SOLUTIONS USA, INC.
- EzDent-i / E2 / Prora View by Ewoosoft Co., Ltd.
- TOMTEC-ARENA by Tomtec Imaging Systems GmbH
- R2 FAMILY OF IMAGE DISPLAY UNITS WITH R2 UNIFORM DISPLAY SOFTWARE by R2 Technology, Inc.
- ATHEROEDGE by Atheropoint, LLC
- Implant Studio R1.3 by 3Shape A/S