Coronis Fusion 6MP - MDCC-6530, Coronis Fusion 4MP - MDCC-4430, Intuitive Workflow Tools (IWT)
FDA 510(k) clearance K191845 · decided 2019-09-06
Clearance details
- K-number
- K191845
- Device name
- Coronis Fusion 6MP - MDCC-6530, Coronis Fusion 4MP - MDCC-4430, Intuitive Workflow Tools (IWT)
- Applicant
- Barco N.V.
- Decision
- Substantially Equivalent
- Date received
- 2019-07-10
- Decision date
- 2019-09-06
- Days to decision
- 58 days
- Clearance type
- Traditional
- Product code
- PGY
- Device class
- 2
- Regulation number
- 892.2050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Kortrijk, BE
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Barco N.V.
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
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.