CRONEX QUANTA SR300 INTENSIFYING SCREEN
FDA 510(k) clearance K900103 · decided 1990-02-05
Clearance details
- K-number
- K900103
- Device name
- CRONEX QUANTA SR300 INTENSIFYING SCREEN
- Applicant
- E.I. Dupont DE Nemours & Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-01-09
- Decision date
- 1990-02-05
- Days to decision
- 27 days
- Clearance type
- Traditional
- Product code
- EAM
- Device class
- 1
- Regulation number
- 892.1960
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Wilmington, DE, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.