510(k) K193317
- Device
- CoreLite X-Ray Specimen Cabinet
- Applicant
- Cirdan Imaging Limited
- 510(k) number
- K193317
- Product code
- MWP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-12-13
- Date received
- 2019-11-29
- Regulation
- 892.1680
- Classification name
- Cabinet, X-ray System
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- Yes
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Jenna McGarry
- Address
- 8 Enterprise Crescent, Ballinderry Rd. Lisburn GB BT28 2BP BT28 2BP
FDA Registration Numbers
- 3010478247
- 3006051164
- 3027847687
- 3026962577
- 3005496266
- 3017889703
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 05060508820017 | CoreLite | CIRDAN IMAGING LIMITED | 2020-03-31 |
Legacy Summary
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FDA Review
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