PlutoX Digital Intraoral X-Ray Imaging System
FDA 510(k) clearance K210312 · decided 2021-04-23
Clearance details
- K-number
- K210312
- Device name
- PlutoX Digital Intraoral X-Ray Imaging System
- Applicant
- Iray Technology Taicang , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2021-02-03
- Decision date
- 2021-04-23
- Days to decision
- 79 days
- Clearance type
- Traditional
- Product code
- MUH
- Device class
- 2
- Regulation number
- 872.1800
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Taicang, CN
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Iray Technology Taicang
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.