# K020643: EZ-Scope an & EZ-Scope an Lite

- Pathway: 510(k) (Traditional)
- Applicant: Health Policy Resorters Group, LLC
- Decided: May 28, 2002 after 90 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: 2 generations back to K885054 (1989). 7 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961104: Notebook Imager, Digirad Corp. (1997). Our OCR of the scanned summary read K961004, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Notebook Imager”.
- K992731: E.Cam Computer, Siemens Medical Solutions USA, Inc. (1999) Summary page 1.

## Cited in the summary but kept off the family tree
- K971320: Cre Balloon Dilatation Catheter, Boston Scientific Corp (1997). Our OCR of the scanned summary read K971320, FDA’s number for Cre Balloon Dilatation Catheter (Boston Scientific Corp). Its FDA name has none of the distinctive words the summary uses for the device it names, “Neoprobe 2000 Isotope Probe”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K022342: EZ-Scope an, EZ-Scope Light (2002), 2 descendants of its own
- K093706: Proxiscan Model 101 (2010), 0 descendants of its own
- K092471: Model Sentinella 102 (2009), 0 descendants of its own

## Indications for use
The Anzai eZ-Scope AN Portable Gamma Camera is indicated for use to image the distribution of radionuclides in the human body using planar imaging techniques. The eZ-Scope may be used on pathological specimens if a protective sheath is used.

Source page: https://510kreport.com/device/K020643
Methodology: https://510kreport.com/methodology