510(k) · Cleared
ClearedKHBS (Krishnamurthy Hepato-Biliary Software), Model Version 1.5
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ani-Kal Ii, LLC · IYX Camera, Scintillation (Gamma)
Cleared on Jun 20, 2007 as substantially equivalent to K992731 (Siemens Medical Solutions USA, Inc., 1999) and 3 other predicates after a 51-day review. Its family tree reaches back 3 generations to 1995. 1 of the 8 devices in its family, counting itself, has a Class I recall.
- Decided
- Jun 20, 2007
- Review
- 51 days
- Class
- Class I
- Product code
- IYX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K952674 (1995). 7 ancestors in all, the oldest K892358 (1989). No later device cites it as a predicate yet. 1 of the 8 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK952674 Transact: Attenuation Correction System for the Apex Cardial Gamma…Elscint, Inc. · 1995 · Recalled
- 2 generations backK980959 Vtransact: Attenuation Correction System for Dual-Head Variable…Ge Medical Systems F.I. Haifa · 1998
- 1 generation backK991841 Hawkeye Option for Dual-Head Variable Angle Gamma CameraGe Medical Systems F.I. Haifa · 1999 · Recalled (Class I)
- This deviceK071195 KHBS (Krishnamurthy Hepato-Biliary Software), Model Version 1.5Ani-Kal Ii, LLC · 2007
Class I recalls in this family
- K991841 Hawkeye Option for Dual-Head Variable Angle…direct predicate · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K952674 | Transact: Attenuation Correction System for the Apex Cardial Gamma Camera | Elscint, Inc. | 1995 | 1 |
| −2 | K980959 | Vtransact: Attenuation Correction System for Dual-Head Variable Angle Gamma… | Ge Medical Systems F.I. Haifa | 1998 | — |
| −1 | K991841 | Hawkeye Option for Dual-Head Variable Angle Gamma Camera | Ge Medical Systems F.I. Haifa | 1999 | Class I |
| 0 (this device) | K071195 | KHBS (Krishnamurthy Hepato-Biliary Software), Model Version 1.5 | Ani-Kal Ii, LLC | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1999 | 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.
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 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? (4)
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 |
|---|---|---|---|
| * | K992731 | E.Cam ComputerSummary page 1…evice Comparison: Predicate Device Manfadnrer 510(k) Number E.CAM/E.Soft Siemens Medical Solutions USA, Inc 992731 ICON Computer System Siemens Medical Solutions USA, Inc K.903315 B ADAC Pegasys Phillips Medic… | 1999 |
| * | K903315 | ICONSummary page 1…mber E.CAM/E.Soft Siemens Medical Solutions USA, Inc 992731 ICON Computer System Siemens Medical Solutions USA, Inc K.903315 B ADAC Pegasys Phillips Medical System K892358 fawkcye Option EL GEMS Ltd/GE Medical… | 1991 |
| * | K892358 | Pegasys Nuclear Medicine Imaging ComputerSummary page 1…2731 ICON Computer System Siemens Medical Solutions USA, Inc K.903315 B ADAC Pegasys Phillips Medical System K892358 fawkcye Option EL GEMS Ltd/GE Medical K991841 KHBS is produced specifically for… | 1989 |
| * | K991841 | Hawkeye Option for Dual-Head Variable Angle Gamma CameraSummary page 1…K.903315 B ADAC Pegasys Phillips Medical System K892358 fawkcye Option EL GEMS Ltd/GE Medical K991841 KHBS is produced specifically for analysis of liver and gallbladder function and incorporates many of known funct… | 1999 |
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.
- K991841Hawkeye Option for Dual-Head Variable Angle Gamma CameraGe Medical Systems F.I. Haifa · 1999 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
- 5 of the 7 ancestors have a recall of any class; 1 has a Class I recall.
- 4 other devices also cite its predicate K992731.
How does its category compare?
All IYX devicesIYX Camera, Scintillation (Gamma): FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071195 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071195: KHBS (Krishnamurthy Hepato-Biliary Software), Model Version 1.5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071195
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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