Accusoft
by Direx Systems Corp. 2 variants
510(k) K040474
Accusoft is a medical device (FDA Class II; FDA product code MUJ, System, Planning, Radiation Therapy Treatment) made by Direx Systems Corp., cleared under FDA 510(k) K040474 on 23 Jun 2004, 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 | NumberK040474 | Date23 Jun 2004 | StatusActive |
Official records
- FDA 510(k) database K040474
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MUJ
- Device class
- Class II
- Regulation
- 21 CFR Part 892.5050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
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