FUJINON EDU SYSTEM
FDA 510(k) clearance K894763 · decided 1990-05-22
Clearance details
- K-number
- K894763
- Device name
- FUJINON EDU SYSTEM
- Applicant
- Fujinon, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-07-27
- Decision date
- 1990-05-22
- Days to decision
- 299 days
- Clearance type
- Traditional
- Product code
- ITX
- Device class
- 2
- Regulation number
- 892.1570
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Fujinon
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.