510(k) · Cleared
Recalled · Class II · 2017Griffin Spect/CT Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Adac Laboratories · KPS System, Tomography, Computed, Emission
Cleared on May 24, 2004 as substantially equivalent to K031705 (Adac Laboratories, 2003) and 1 other predicate after a 14-day review. Its family tree reaches back 4 generations to 1993. 1 later device descends from it. It has been recalled 11 times.
- Decided
- May 24, 2004
- Review
- 14 days
- Class
- Class II
- Product code
- KPS
- Recalls
- 11
- Predicates
- 2
Its longest line of descent runs back 4 generations to K930090 (1993). 12 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK930090 HelicatElscint, Inc. · 1993
- 3 generations backK961464 Select/SPElscint, Inc. · 1996 · Recalled
- 2 generations backK982060 Volumax CT Imaging SystemElscint, Inc. · 1998
- 1 generation backK012009 MX8000 Idt CT SystemMarconi Medical Systems, Inc. · 2001 · Recalled
- This deviceK041218 Griffin Spect/CT Imaging SystemAdac Laboratories · 2004
- Descendant · cites it directly · 0 of its ownK051351 Precedence Spect/CT Imaging SystemAdac Laboratories · 2005 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K051351Precedence Spect/CT Imaging SystemAdac Laboratories · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K930090 | Helicat | Elscint, Inc. | 1993 | — |
| −3 | K961464 | Select/SP | Elscint, Inc. | 1996 | 3 |
| −2 | K982060 | Volumax CT Imaging System | Elscint, Inc. | 1998 | — |
| −1 | K012009 | MX8000 Idt CT System | Marconi Medical Systems, Inc. | 2001 | 61 |
| 0 (this device) | K041218 | Griffin Spect/CT Imaging System | Adac Laboratories | 2004 | — |
| +1 | K051351 | Precedence Spect/CT Imaging System | Adac Laboratories | 2005 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KPS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KPS device
- #1 K253564 uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI…score 18.6 · 17 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051351 | Precedence Spect/CT Imaging System | 2005 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 15, 2017 | Class II | Z-0513-2018 | Under Investigation by firm | During collimator exchange, the alignment of the collimator cart and detectors may cause a collimator exchange fail, and a collimator may drop to the floor beside the collimator cart. The collimator may be partially supported by the cart… |
| Dec 15, 2017 | Class II | Z-0514-2018 | Under Investigation by firm | During collimator exchange, the alignment of the collimator cart and detectors may cause a collimator exchange fail, and a collimator may drop to the floor beside the collimator cart. The collimator may be partially supported by the cart… |
| Mar 6, 2015 | Class II | Z-1778-2015 | Nonconforming Material/Component | The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes. |
| Mar 6, 2015 | Class II | Z-1779-2015 | Nonconforming Material/Component | The firm was notified that the failure of the UPS accessory devices used in conjunction with Computed Tomography X-ray systems and Diagnostic Imaging systems. may result in battery acid leakage, overheating and/or emission of fumes. |
| Sep 27, 2011 | Not classified | Z-0255-2012 | Device Design | A mechanical malfunction of the button on the hand controller on the Philips Precedence and SKYLight SPECT systems may get stuck and cause unintended motion of a detector. |
| Sep 27, 2011 | Not classified | Z-0257-2012 | Device Design | A mechanical malfunction of the button on the hand controller on the Philips Precedence and SKYLight SPECT systems may get stuck and cause unintended motion of a detector. |
| Sep 27, 2011 | Not classified | Z-0256-2012 | Device Design | A mechanical malfunction of the button on the hand controller on the Philips Precedence and SKYLight SPECT systems may get stuck and cause unintended motion of a detector. |
| Sep 27, 2011 | Not classified | Z-0258-2012 | Device Design | A mechanical malfunction of the button on the hand controller on the Philips Precedence and SKYLight SPECT systems may get stuck and cause unintended motion of a detector. |
| Dec 28, 2010 | Not classified | Z-1549-2011 | Other | Philips Healthcare Nuclear Medicine determined that the detector arm assembly could be compromised. |
| Dec 28, 2010 | Not classified | Z-1550-2011 | Other | Philips Healthcare Nuclear Medicine determined that the detector arm assembly could be compromised. |
| Sep 28, 2007 | Not classified | Z-0676-2008 | Software design | Incorrect Measurement: The firm discovered a software defect in Cardiac and Pulmonary Viewer software application options used in the Precedence CT Sub-System. The defect causes incorrect measurements in derived images which are zoomed… |
The 5 latest of 11 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- 4 of the 12 ancestors have a recall of any class.
- Of its descendants, K051351 (Adac Laboratories, 2005) has gone furthest, with 0 descendants of its own.
How does its category compare?
All KPS devicesKPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KPS
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KPS
65in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KPS
16in 2025
Class I (17 since 2007) Class II/III not classified
Adverse event reports per year · KPS
36in 2025
MAUDE reports naming product code KPS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 8 | 38 | 22 | 38 |
| 2008 | 17 | 25 | 16 | 11 |
| 2009 | 9 | 42 | 14 | 15 |
| 2010 | 3 | 91 | 4 | 44 |
| 2011 | 7 | 28 | 34 | 56 |
| 2012 | 6 | 94 | 13 | 34 |
| 2013 | 11 | 84 | 13 | 240 |
| 2014 | 11 | 92 | 18 | 33 |
| 2015 | 3 | 112 | 5 | 24 |
| 2016 | 11 | 65 | 16 | 10 |
| 2017 | 11 | 104 | 11 | 31 |
| 2018 | 13 | 59 | 12 (3) | 26 |
| 2019 | 3 | 60 | 5 (5) | 105 |
| 2020 | 12 | 72 | 8 | 22 |
| 2021 | 15 | 66 | 4 | 10 |
| 2022 | 5 | 60 | 8 (6) | 15 |
| 2023 | 12 | 63 | 6 (3) | 22 |
| 2024 | 11 | 59 | 15 | 23 |
| 2025 | 12 | 65 | 16 | 36 |
| 2026 | 6 | 67 | 6 | — |
What is it indicated for?
Griffin is an imaging system combining the acquisition of single photon nuclear medicine images and images from an x-ray computed tomography system. Griffin may produce non-attenuation corrected and attenuation corrected images of the distribution of radiopharmaceuticals in the body as well as x-ray transmission images. The CT transmission data may be used to produce attenuation corrected nuclear medicine images. The nuclear medicine images and the CT…
Read the full statement (152 words)
Griffin is an imaging system combining the acquisition of single photon nuclear medicine images and images from an x-ray computed tomography system. Griffin may produce non-attenuation corrected and attenuation corrected images of the distribution of radiopharmaceuticals in the body as well as x-ray transmission images. The CT transmission data may be used to produce attenuation corrected nuclear medicine images. The nuclear medicine images and the CT images may be registered and displayed in a fused format (overlaid in the same orientation) to provide combined single photon and anatomical data for anatomical localization of the nuclear medicine data. Griffin may be used either as a separate single photon system, a separate CT system or as a combined CT and single photon system. The nuclear medicine and CT images may be transferred to other systems such as a radiation therapy planning system. The Griffin Imaging System should only be used by trained healthcare professionals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041218 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041218: Griffin Spect/CT Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041218
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026