Standard Imaging E.imrt Calculator
510(k) K040688
Standard Imaging E.imrt Calculator is a medical device (FDA Class II; FDA product code MUJ, System, Planning, Radiation Therapy Treatment) made by Standard Imaging Inc., cleared under FDA 510(k) K040688 on 11 May 2004, active as of 8 Nov 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 | NumberK040688 | Date11 May 2004 | StatusActive |
Official records
- FDA 510(k) database K040688
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MUJ
- FDA applicant
- Standard Imaging, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 892.5050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
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