Autospect
by Philips Medical Systems (Cleveland), Inc.
510(k) K090403
Autospect is a medical device (FDA Class II; FDA product code KPS, System, Tomography, Computed, Emission) made by Philips Medical Systems (Cleveland), Inc., cleared under FDA 510(k) K090403 on 31 Mar 2009, active as of 22 Oct 2026. 2 FDA recalls are 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 | NumberK090403 | Date31 Mar 2009 | StatusActive |
Official records
- FDA 510(k) database K090403
Recalls
-
- Terminated Z-1504-2016
- Terminated Z-1505-2016
The AutoSPECT Pro application was only designed to reconstruct cardiac SPECT data obtained with detectors positioned at 90 or 180 relative to one another. However, certain gamma cameras allow for other relative detector angles. Data acquired at these other angles will not be correctly reconstructed by AutoSPECT Pro and the results will likely be erroneous.
Timeline
- Cleared FDA 510(k) K090403
- Recall initiated FDA recalls Z-1504-2016
- Recall initiated FDA recalls Z-1505-2016
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KPS
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1200
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
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