510(k) K041218 ยท KPS System, Tomography, Computed, Emission
GRIFFIN SPECT/CT IMAGING SYSTEM
| Applicant | Adac Laboratories, Milpitas CA, US |
| Decision | Substantially Equivalent, May 24, 2004 |
| Received | May 10, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041218
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 3, 2018 | Philips Medical Systems (Cleveland) Inc Precedence 6 Model # 882351
Product Usage:
Precedence (cleared as Griffin) is an imaging system combining the acquisition of single photon nuclear medicine images and images from an x-ray computed to Terminated |
KPS | None listed |
| Feb 3, 2018 | Philips Medical Systems (Cleveland) Inc Precedence 16 Model # 882350
Product Usage:
Precedence (cleared as Griffin) is an imaging system combining the acquisition of single photon nuclear medicine images and images from an x-ray computed t Terminated |
KPS | None listed |
| Jun 11, 2015 | Philips Medical Systems (Cleveland) Inc Precedence 16 (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems. Terminated |
KPS | None listed |
| Jun 11, 2015 | Philips Medical Systems (Cleveland) Inc Precedence 6 (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems. Terminated |
KPS | None listed |
| Nov 19, 2011 | Philips Medical Systems Precedence System;
SYST,PRECEDENCE, 16 SLICE 5/8
Manufactured by Philips Medical Systems (Cleveland), Inc.
595 Miner Road, Cleveland, OH 44143.
The SKYLight Gamma Camera System is intended to produc Terminated |
KPS | None listed |
| Nov 19, 2011 | Philips Medical Systems Precedence System;
SYST,PRECEDENCE, 16 SLICE 3/8
Manufactured by Philips Medical Systems (Cleveland), Inc.
595 Miner Road, Cleveland, OH 44143.
The SKYLight Gamma Camera System is intended to produc Terminated |
KPS | None listed |
| Nov 19, 2011 | Philips Medical Systems Precedence System;
SYST,PRECEDENCE, 6 SLICE 3/8
Manufactured by Philips Medical Systems (Cleveland), Inc.
595 Miner Road, Cleveland, OH 44143.
The SKYLight Gamma Camera System is intended to product Terminated |
KPS | None listed |
| Nov 19, 2011 | Philips Medical Systems Precedence System;
SYST,PRECEDENCE, 6 SLICE 5/8
Manufactured by Philips Medical Systems (Cleveland), Inc.
595 Miner Road, Cleveland, OH 44143.
The SKYLight Gamma Camera System is intended to product Terminated |
KPS | None listed |
| Mar 4, 2011 | Philips Medical Systems Precedence Imaging System; 16 Slice 5/8, 16 slice 3/8;
Philips Medical Systems
An imaging system combining the acquisition of single photon nuclear medicine images and images from an x-ray computed t Terminated |
JAK | None listed |
| Mar 4, 2011 | Philips Medical Systems Precedence Imaging System; 6 Slice 3/8; 6 slice 5/8
Philips Medical Systems
An imaging system combining the acquisition of single photon nuclear medicine images and images from an x-ray computed tomo Terminated |
JAK | None listed |
| Feb 8, 2008 | Phillips Nuclear Medicine Philips Medical Systems -- Cardiac Viewer or Pulmonary Viewer software application version 2.0 in use with Precedence SPECT/CT System and all CT EBW workstations using software version 3.5. Philips N Terminated |
KPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.