# K961104: Notebook Imager

- Pathway: 510(k) (Traditional)
- Applicant: Digirad Corp.
- Decided: May 28, 1997 after 434 days
- Product code: IYX (Camera, Scintillation (Gamma))
- Device class: 1
- Regulation: 21 CFR 892.1100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K885054 (1989). 2 ancestors in all.
13 later devices descend from it; 4 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K921296: ADAC S315, Adac Laboratories (1992) Summary page 1.
- K885054: System Seventy Seven, Scinticor, Inc. (1989) Summary page 1.
- (no number) Elscint Apex SPX-4: named in the summary without a submission number

## Most influential descendants
- K993813: Lumagem Scintillation Camera (2000), 5 descendants of its own
- K102231: Discovery NM 750B (2010), 3 descendants of its own
- K020643: EZ-Scope an & EZ-Scope an Lite (2002), 3 descendants of its own
- K100838: Ergo Imaging System (2010), 2 descendants of its own
- K022342: EZ-Scope an, EZ-Scope Light (2002), 2 descendants of its own

## Indications for use
For Nuclear Medicine Imaging Device A. Planar imaging — 30-300 KeV

Source page: https://510kreport.com/device/K961104
Methodology: https://510kreport.com/methodology