510(k) · Cleared
ClearedQuantem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elscint, Inc. · KPS System, Tomography, Computed, Emission
Cleared on Nov 12, 1996 as substantially equivalent to K932957 (GE Medical Systems, 1993) and 1 other predicate after a 90-day review. Its family tree reaches back 1 generation to 1993. 1 of the 3 devices in its family, counting itself, has a Class I recall.
- Decided
- Nov 12, 1996
- Review
- 90 days
- Class
- Class II
- Product code
- KPS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K932957 (1993). 2 ancestors in all. No later device cites it as a predicate yet. 1 of the 3 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK932957 Quantem (TM)GE Medical Systems · 1993
- This deviceK963162 QuantemElscint, Inc. · 1996
Class I recalls in this family
- K953801 Varicamdirect predicate · 1995
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K932957 | Quantem (TM) | GE Medical Systems | 1993 | — |
| 0 (this device) | K963162 | Quantem | Elscint, Inc. | 1996 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 1 |
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.
1 device in this family has a Class I recall. 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 18.7 · 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K932957 | Quantem (TM)Summary page 1…ffectiveness of the QuantEM "™ package, implemented on the Apex XPert, is equivalent to the effectiveness of the QuantEM'™ package implemented on GE Starcam computers (K932957). The addition of the QuantEM ™ package does not effect the safety and effectiveness of all other functions performed by the Ap… | 1993 |
| * | K953801 | VaricamSummary page 1…physician in the performance and interpretation of Tc99m MAG3 renograms The QuantEM™ package is implemented on the Apex XPert workstation of the Varicam gamma camera (K953801) The effectiveness of the QuantEM "™ package, implemented on the Apex XPert, is equivalent to the effectiveness of the QuantEM'™… | 1995 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K953801VaricamElscint, Inc. · 1995 · Direct predicate · ◆ in the 1995 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- 1 of the 2 ancestors has a recall of any class; 1 has a Class I recall.
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?
QuantEM™ package is a renal analysis package for Tc-99m MAGS3 renal images.
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/K963162 · printed Nov 4, 2026
Cite this page
510(k) Report. “K963162: Quantem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963162
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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