510(k) K242545
- Device
- RadiForce MX317W-PA
- Applicant
- Eizo Corporation
- 510(k) number
- K242545
- Product code
- PZZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-05-23
- Date received
- 2024-08-27
- Regulation
- 864.3700
- Classification name
- Digital Pathology Display
- Medical specialty
- Pathology
- Review panel
- Pathology
- Device class
- 2
- Clearance type
- Abbreviated
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Hiroaki Hashimoto
- Address
- 153 Shimokashiwano Hakusan JP 924-8566 924-8566
FDA Registration Numbers#
- 1000181154
- 9613188
- 3031232523
- 3008481104
- 3003584784