ACU007S
510(k) K092522
ACU007S is a medical device (FDA Class II; FDA product code KXK, Source, Brachytherapy, Radionuclide) made by Oncology Systems, Inc., cleared under FDA 510(k) K092522 on 20 Nov 2009, active as of 10 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 | NumberK092522 | Date20 Nov 2009 | StatusActive |
Official records
- FDA 510(k) database K092522
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KXK
- Device class
- Class II
- Regulation
- 21 CFR Part 892.5730
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
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