NanoZoomer S360MD Slide scanner system
FDA 510(k) clearance K213883 · decided 2022-09-27
Clearance details
- K-number
- K213883
- Device name
- NanoZoomer S360MD Slide scanner system
- Applicant
- Hamamatsu Photonics K.K.
- Decision
- Substantially Equivalent
- Date received
- 2021-12-13
- Decision date
- 2022-09-27
- Days to decision
- 288 days
- Clearance type
- Traditional
- Product code
- PSY
- Device class
- 2
- Regulation number
- 864.3700
- Medical specialty
- Pathology
- Advisory committee
- Pathology
- Location
- Hamamatsu City, JP
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Hamamatsu Photonics K.K.
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
| Record | Firm | Date |
|---|---|---|
| NanoZoomer S360MD Slide scanner system-automated system for creating, viewing, and managin recall (Z-2280-2023) | Hamamatsu Corporation | 2023-08-01 |