510(k) · Cleared
ClearedNotebook Imager
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Digirad Corp. · IYX Camera, Scintillation (Gamma)
Cleared on May 28, 1997 as substantially equivalent to K921296 (Adac Laboratories, 1992) and 1 other predicate after a 434-day review. Its family tree reaches back 1 generation to 1989. 13 later devices descend from it.
- Decided
- May 28, 1997
- Review
- 434 days
- Class
- Class I
- Product code
- IYX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K885054 (1989). 2 ancestors in all. 13 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK885054 System Seventy SevenScinticor, Inc. · 1989
- This deviceK961104 Notebook ImagerDigirad Corp. · 1997
- Descendant · cites it directly · 5 of its ownK993813 Lumagem Scintillation CameraGamma Medica · 2000
- Descendant · 2 generations on · 3 of its ownK102231 Discovery NM 750BGe Medical Systems Israel, Functional Imaging · 2010
- Descendant · cites it directly · 3 of its ownK020643 EZ-Scope an & EZ-Scope an LiteHealth Policy Resorters Group, LLC · 2002
- Descendant · cites it directly · 2 of its ownK100838 Ergo Imaging SystemDigirad Corp. · 2010
- Descendant · 2 generations on · 2 of its ownK022342 EZ-Scope an, EZ-Scope LightAnzai Medical Co., Ltd. · 2002
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K993813Lumagem Scintillation CameraGamma Medica · 2000 · cites it directly5descendants
- K102231Discovery NM 750BGe Medical Systems Israel, Functional Imaging · 2010 · 2 generations on3descendants
- K020643EZ-Scope an & EZ-Scope an LiteHealth Policy Resorters Group, LLC · 2002 · cites it directly3descendants
- K100838Ergo Imaging SystemDigirad Corp. · 2010 · cites it directly2descendants
- K022342EZ-Scope an, EZ-Scope LightAnzai Medical Co., Ltd. · 2002 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K885054 | System Seventy Seven | Scinticor, Inc. | 1989 | — |
| 0 (this device) | K961104 | Notebook Imager | Digirad Corp. | 1997 | — |
| +1 | K993813 | Lumagem Scintillation Camera | Gamma Medica | 2000 | — |
| +2 | K102231 | Discovery NM 750B | Ge Medical Systems Israel, Functional Imaging | 2010 | — |
| +1 | K020643 | EZ-Scope an & EZ-Scope an Lite | Health Policy Resorters Group, LLC | 2002 | — |
| +1 | K100838 | Ergo Imaging System | Digirad Corp. | 2010 | — |
| +2 | K022342 | EZ-Scope an, EZ-Scope Light | Anzai Medical Co., Ltd. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2016 | 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 IYX? 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 IYX device
- #1 K230221 QDOSE® Multi-purpose Voxel Dosimetry…score 6.2 · 2 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K921296 | ADAC S315Summary page 1…fication Name: Scintillation (gamma) camera Common/Usual Name: Gamma Camera Trade Name: Notebook Imager™ C. Predicate Devices: Sponsor Product 510(k) No. ADAC Transcam K921296 ELSCINT APEX SPX-4 OB umlcpowm SCINTICOR SIM 400 K885054 D. Device Description: The Notebook Imager™ system is a gamma camera wh… | 1992 |
| * | K885054 | System Seventy SevenSummary page 1…Name: Gamma Camera Trade Name: Notebook Imager™ C. Predicate Devices: Sponsor Product 510(k) No. ADAC Transcam K921296 ELSCINT APEX SPX-4 OB umlcpowm SCINTICOR SIM 400 K885054 D. Device Description: The Notebook Imager™ system is a gamma camera which consists of an Imaging Head, an Arm and Cart assembly… | 1989 |
| * | — | Elscint Apex SPX-4 Named without a submission number |
What descends from it? (13)
See all 134 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All IYX devicesIYX Camera, Scintillation (Gamma): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IYX
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · IYX
82in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYX
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYX
1in 2022
MAUDE reports naming product code IYX, 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 | 2 | — | 0 | 11 |
| 2008 | 2 | — | 0 | 10 |
| 2009 | 2 | — | 0 | 8 |
| 2010 | 4 | 82 | 0 | 5 |
| 2011 | 3 | 82 | 0 | 6 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 4 |
| 2016 | 2 | — | 0 | 2 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 2 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
For Nuclear Medicine Imaging Device
A. Planar imaging — 30-300 KeV
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/K961104 · printed Nov 6, 2026
Cite this page
510(k) Report. “K961104: Notebook Imager.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961104
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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