Integra Immobilization System
by Diacor Inc.
510(k) K050888
Integra Immobilization System is a medical device (FDA Class II; FDA product code IYE, Accelerator, Linear, Medical) made by Diacor Inc., cleared under FDA 510(k) K050888 on 23 May 2005, 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 | NumberK050888 | Date23 May 2005 | StatusActive |
Official records
- FDA 510(k) database K050888
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- IYE
- FDA applicant
- Diacor, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 892.5050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
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