510(k) · Cleared
Recalled · Class II · 2012Gemini Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Adac Laboratories · JAK System, X-Ray, Tomography, Computed
Cleared on Nov 7, 2001 as substantially equivalent to K010641 (Ge Medical Systems, Inc., 2001) and 1 other predicate after a 15-day review. Its family tree reaches back 1 generation to 2000. 88 later devices descend from it. It has been recalled 2 times.
- Decided
- Nov 7, 2001
- Review
- 15 days
- Class
- Class II
- Product code
- JAK
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 1 generation to K002715 (2000). 2 ancestors in all. 88 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK002715 Ecat Pet ScannerCti Pet Systems, Inc. · 2000 · Recalled
- This deviceK013521 Gemini Imaging SystemAdac Laboratories · 2001
- Descendant · cites it directly · 87 of its ownK032036 Gemini 16Philips Medical Systems (Cleveland), Inc. · 2003 · Recalled
- Descendant · 2 generations on · 65 of its ownK041955 Gemini Pet/CT Imaging SystemPhilips Medical Systems (Cleveland), Inc. · 2004 · Recalled
- Descendant · 3 generations on · 49 of its ownK062650 EP Navigator SoftwarePhilips Medical Systems · 2006
- Descendant · 4 generations on · 41 of its ownK101311 EP Navigator R3Philips Medical Systems North America Co. · 2010
- Descendant · 5 generations on · 39 of its ownK111245 Heartnavigator Release 1Philips Medical Systems Nederland B.V. · 2011
Showing 5 of 88 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 88 · See all- K032036Gemini 16Philips Medical Systems (Cleveland), Inc. · 2003 · cites it directly87descendants
- K041955Gemini Pet/CT Imaging SystemPhilips Medical Systems (Cleveland), Inc. · 2004 · 2 generations on65descendants
- K062650EP Navigator SoftwarePhilips Medical Systems · 2006 · 3 generations on49descendants
- K101311EP Navigator R3Philips Medical Systems North America Co. · 2010 · 4 generations on41descendants
- K111245Heartnavigator Release 1Philips Medical Systems Nederland B.V. · 2011 · 5 generations on39descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002715 | Ecat Pet Scanner | Cti Pet Systems, Inc. | 2000 | 2 |
| 0 (this device) | K013521 | Gemini Imaging System | Adac Laboratories | 2001 | — |
| +1 | K032036 | Gemini 16 | Philips Medical Systems (Cleveland), Inc. | 2003 | 2 |
| +2 | K041955 | Gemini Pet/CT Imaging System | Philips Medical Systems (Cleveland), Inc. | 2004 | 2 |
| +3 | K062650 | EP Navigator Software | Philips Medical Systems | 2006 | — |
| +4 | K101311 | EP Navigator R3 | Philips Medical Systems North America Co. | 2010 | — |
| +5 | K111245 | Heartnavigator Release 1 | Philips Medical Systems Nederland B.V. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 4 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 7 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 4 | 0 |
| 2018 | 6 | 0 |
| 2020 | 4 | 0 |
| 2021 | 6 | 0 |
| 2022 | 5 | 0 |
| 2023 | 7 | 0 |
| 2024 | 6 | 0 |
| 2025 | 11 | 0 |
| 2026 | 8 | 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 JAK? 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 JAK device
- #1 K230223 iCAC Devicescore 23.5 · 12 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K010641 | GE CT-Pet SystemSummary page 2…lectrical, mechanical, and radiation have been minimized. L Conclusion: The GEMINI Imaging System is substantially equivalent to the predicate devices, the GE CT- PET (K010641) and the EXACT CT-PET (K002715) based upon similar intended use, technological comparison, and system performance. b4 GEMINI 510… | 2001 |
| * | K002715 | Ecat Pet ScannerSummary page 2…ation have been minimized. L Conclusion: The GEMINI Imaging System is substantially equivalent to the predicate devices, the GE CT- PET (K010641) and the EXACT CT-PET (K002715) based upon similar intended use, technological comparison, and system performance. b4 GEMINI 510(k) Notification Section X.-1-2… | 2000 |
What descends from it? (88)
See all 881 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032036 | Gemini 16 | 2003 | 87 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 21, 2012 | Class II | Z-2451-2012 | Nonconforming Material/Component | A bolt which attaches the oil accumulator within the gantry may fail, resulting in the oil accumulator detaching from the tube housing assembly within the gantry. |
| Mar 11, 2005 | Not classified | Z-1417-05 | Other | When two product applications called Flip and Secondary Capture are used together, it is possible for image orientation labels to be incorrect. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All JAK devicesJAK System, X-Ray, Tomography, Computed: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JAK
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAK
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAK
17in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAK
219in 2025
MAUDE reports naming product code JAK, 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 | 14 | 27 | 11 | 76 |
| 2008 | 26 | 42 | 16 | 120 |
| 2009 | 15 | 31 | 29 | 105 |
| 2010 | 7 | 92 | 51 | 119 |
| 2011 | 16 | 155 | 34 | 205 |
| 2012 | 28 | 121 | 23 | 192 |
| 2013 | 17 | 132 | 11 | 414 |
| 2014 | 30 | 200 | 10 | 308 |
| 2015 | 30 | 140 | 28 | 454 |
| 2016 | 25 | 129 | 44 | 365 |
| 2017 | 29 | 96 | 33 | 338 |
| 2018 | 24 | 114 | 10 | 543 |
| 2019 | 28 | 94 | 5 | 233 |
| 2020 | 30 | 112 | 8 | 177 |
| 2021 | 20 | 145 | 15 | 261 |
| 2022 | 30 | 131 | 9 | 199 |
| 2023 | 27 | 139 | 9 | 310 |
| 2024 | 26 | 141 | 20 | 212 |
| 2025 | 27 | 141 | 17 | 219 |
| 2026 | 21 | 167 | 23 | — |
What is it indicated for?
GEMINI is an imaging system that combines positron emission tomography (PET) and X-ray computed tomography. The GEMINI produces attenuation and non-attenuation corrected images of the distribution of PET radiopharmaceuticals in the head, body and total body as well as x-ray transmission images of these areas. The PET and CT images are registered and displayed in a “fused” format to provide combined PET and anatomical data at different angles for interpretation by trained health professionals. The PET and CT portions of the system can be used either as an integrated system or as a stand-alone PET or CT system. GEMINI can provide CT data suitable for use in attenuation correction.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013521 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013521: Gemini 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/K013521
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026