Ophthalmic Software Platform RX
FDA 510(k) clearance K173689 · decided 2018-02-23
Clearance details
- K-number
- K173689
- Device name
- Ophthalmic Software Platform RX
- Applicant
- Canon Inc. -Medical Equipment Group
- Decision
- Substantially Equivalent
- Date received
- 2017-12-01
- Decision date
- 2018-02-23
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- NFJ
- Device class
- 2
- Regulation number
- 892.2050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Nakahara-Ku, Kawasaki, JP
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.