Dendrite Imaging System
FDA 510(k) clearance K253303 · decided 2025-11-28
Clearance details
- K-number
- K253303
- Device name
- Dendrite Imaging System
- Applicant
- Dendrite Imaging, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-09-29
- Decision date
- 2025-11-28
- Days to decision
- 60 days
- Clearance type
- Traditional
- Product code
- QDG
- Device class
- 2
- Regulation number
- 878.4550
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Berkeley, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Dendrite Imaging
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM) (K250455) | Fluoptics Sas (A Getinge Group Company} | 2025-04-17 |
| FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR) (K233564) | Fluoptics Sas (A Getinge Group Company) | 2023-12-15 |
| FLUOBEAM® LX Red (K230898) | Fluoptics Sas | 2023-07-28 |
| Fluobeam LX (K190891) | Fluoptics | 2019-07-31 |
| Fluobeam 800 Clinic Imaging Device used with Fluocase 800 Control System (DEN170092) | Fluoptics | 2018-11-02 |
Recalls involving this device
No recalls on record reference this clearance.