DELTA4
by Scandidos AB
510(k) K052920
DELTA4 is a medical device (FDA Class II; FDA product code IYE, Accelerator, Linear, Medical) made by Scandidos AB, cleared under FDA 510(k) K052920 on 12 Jan 2006, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK052920 | Date12 Jan 2006 | StatusActive |
Official records
- FDA 510(k) database K052920
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- IYE
- Device class
- Class II
- Regulation
- 21 CFR Part 892.5050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
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