PerfusiX-Imaging
FDA 510(k) clearance K254180 · decided 2026-07-24
Clearance details
- K-number
- K254180
- Device name
- PerfusiX-Imaging
- Applicant
- LIMIS Development B.V.
- Decision
- Substantially Equivalent
- Date received
- 2025-12-23
- Decision date
- 2026-07-24
- Days to decision
- 213 days
- Clearance type
- Traditional
- Product code
- OWN
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Leeuwarden, NL
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch LIMIS Development B.V.
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.
Recalls involving this device
No recalls on record reference this clearance.