510(k) K000908 ยท KPS System, Tomography, Computed, Emission
SKYLIGHT IMAGING SYSTEM
| Applicant | Adac Laboratories, Milpitas CA, US |
| Decision | Substantially Equivalent, Apr 5, 2000 |
| Received | Mar 21, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000908
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 16, 2012 | Philips Medical Systems (Cleveland) Inc The Brilliance Workspace Portal is a software component of the Computed Tomography X-Ray System.
The Brilliance Workspace Portal is a software component of the Computed Tomography X-Ray System that Terminated |
KPS | None listed |
| Jan 11, 2012 | Philips Medical Systems SKYLight Imaging Systems, Model 882050;
Intended to produce images depicting the anatomical distributions of single photon and positron emitting radioisotopes within the human body for interpretation Terminated |
KPS | None listed |
| Nov 19, 2011 | Philips Medical Systems SKYLight Gamma Camera System;
SKYLIGHT 8FT, 3/8" SPECT
Manufactured by Philips Medical Systems (Cleveland), Inc.
595 Miner Road, Cleveland, OH 44143.
The SKYLight Gamma Camera System is intended to Terminated |
KPS | None listed |
| Nov 19, 2011 | Philips Medical Systems SKYLight Gamma Camera System;
SKYLIGHT 8FT, 5/8" SPECT
Manufactured by Philips Medical Systems (Cleveland), Inc.
595 Miner Road, Cleveland, OH 44143.
The SKYLight Gamma Camera System is intended to Terminated |
KPS | None listed |
| Nov 19, 2011 | Philips Medical Systems SKYLight Gamma Camera System;
SKYLIGHT, 3/8",SPECT;
Manufactured by Philips Medical Systems (Cleveland), Inc.
595 Miner Road, Cleveland, OH 44143.
The SKYLight Gamma Camera System is intended to prod Terminated |
KPS | None listed |
| Nov 19, 2011 | Philips Medical Systems SKYLight Gamma Camera System;
SKYLIGHT, 5/8",SPECT;
Manufactured by Philips Medical Systems (Cleveland), Inc.
595 Miner Road, Cleveland, OH 44143.
The SKYLight Gamma Camera System is intended to prod Terminated |
KPS | None listed |
| Nov 19, 2011 | Philips Medical Systems SKYLight Gamma Camera System;
SKYLIGHT,AZ,8FT,3/8
Manufactured by Philips Medical Systems (Cleveland), Inc.
595 Miner Road, Cleveland, OH 44143.
The SKYLight Gamma Camera System is intended to produ Terminated |
KPS | None listed |
| Nov 19, 2011 | Philips Medical Systems SKYLight Gamma Camera System;
SKYLIGHT,AZ,8FT,5/8
Manufactured by Philips Medical Systems (Cleveland), Inc.
595 Miner Road, Cleveland, OH 44143.
The SKYLight Gamma Camera System is intended to produ Terminated |
KPS | None listed |
| Nov 19, 2011 | Philips Medical Systems SKYLight Gamma Camera System;
SKYLIGHT,AZ,9FT,3/8
Manufactured by Philips Medical Systems (Cleveland), Inc.
595 Miner Road, Cleveland, OH 44143.
The SKYLight Gamma Camera System is intended to produ Terminated |
KPS | None listed |
| Nov 19, 2011 | Philips Medical Systems SKYLight Gamma Camera System;
SKYLIGHT,AZ,9FT,5/8
Manufactured by Philips Medical Systems (Cleveland), Inc.
595 Miner Road, Cleveland, OH 44143.
The SKYLight Gamma Camera System is intended to produ Terminated |
KPS | None listed |
| Mar 4, 2011 | Philips Medical Systems SKYLight 8 FT 3/8" SPECT; 9 FT 3/8", SPECT; 8 FT, 5/8" SPECT; and 9 FT 5/8" SPECT.
Philips Medical Systems
Intended to produce images depicting the anatomical distribution of single photon and positr Terminated |
KPS | None listed |
| Mar 4, 2011 | Philips Medical Systems SKYLight, AZ 8 FT 3/8"; 8 FT, 5/8"; 9 FT 3/8"; and 9 FT 5/8".
Philips Medical Systems
Intended to produce images depicting the anatomical distribution of single photon and positron emitting radioisot Terminated |
KPS | None listed |
| Nov 17, 2010 | Philips Medical Systems SKYLight Gamma Camera Gearbox brake, a component of the SKYLight Gamma Cameras 3/8" SPECT, Model number 4535 600 66661; and 5/8" SPECT, Model number 4535 602 20381, manufactured by Philips Medical Sys Terminated |
KPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.