Fluorospot Compact
by Siemens Medical Solutions USA, Inc.
510(k) K982028
Fluorospot Compact is a medical device (FDA Class II; FDA product code JAA, System, X-Ray, Fluoroscopic, Image-Intensified) made by Siemens Medical Solutions USA, Inc., cleared under FDA 510(k) K982028 on 14 Jul 1998, 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 | NumberK982028 | Date14 Jul 1998 | StatusActive |
Official records
- FDA 510(k) database K982028
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- JAA
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1650
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
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