# K071195: KHBS (Krishnamurthy Hepato-Biliary Software), Model Version 1.5

- Pathway: 510(k) (Traditional)
- Applicant: Ani-Kal Ii, LLC
- Decided: Jun 20, 2007 after 51 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: 3 generations back to K952674 (1995). 7 ancestors in all.
No later device cites it as a predicate yet.
1 of 8 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992731: E.Cam Computer, Siemens Medical Solutions USA, Inc. (1999) Summary page 1.
- K903315: ICON, Siemens Gammasonics, Inc. (1991) Summary page 1.
- K892358: Pegasys Nuclear Medicine Imaging Computer, Adac Laboratories (1989) Summary page 1.
- K991841: Hawkeye Option for Dual-Head Variable Angle Gamma Camera, Ge Medical Systems F.I. Haifa (1999) Summary page 1.

## Indications for use
KHBS is an "Off the Shelfr software uted for analysis of liver and gallbladder function studies obtained with quantitative a scintillation gamma camera. The Dicom image data obtained with the scintillation garaa camera is transferred to the software loaded on to a network PC and analyzed by a person familiar with the use of nuclear medicine equipment.

Source page: https://510kreport.com/device/K071195
Methodology: https://510kreport.com/methodology