Smart Spot
by CMT Medical Technologies, Ltd.
510(k) K961307
Smart Spot is a Class II device made by CMT Medical Technologies, Ltd., cleared under FDA 510(k) K961307 on 1 Jul 1996, active as of 22 Oct 2026. One FDA recall is linked to it.
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK961307 | Date1 Jul 1996 | StatusActive |
Official records
- FDA 510(k) database K961307
Recalls
-
- Terminated Z-0533-06
When the error condition occurs the x-ray exposures will terminate immediately. The digital system (EPS-Plus/ADR-1000A) will immediately stop acquiring images or will continue to acquire blank images. The remote console will lock-up upon release of the hand switch. The operator must reboot the system. This will result in the loss of the images acquired during the contrast portion of the study.
Timeline
- Cleared FDA 510(k) K961307
- Recall initiated FDA recalls Z-0533-06
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LLZ
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
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