510(k) · Cleared
ClearedAxis Pacs, HMS Pacs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Axis Health Care, LLC · LLZ System, Image Processing, Radiological
Cleared on Mar 3, 2011 as substantially equivalent to K020995 (Efilm Medical, Inc., 2002) after a 76-day review. Its family tree reaches back 5 generations to 1990.
- Decided
- Mar 3, 2011
- Review
- 76 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K896095 (1990). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 4 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 3 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 2 generations backK012211 Efilm WorkstationEfilm Medical, Inc. · 2001 · Recalled
- 1 generation backK020995 Efilm Workstation with ModulesEfilm Medical, Inc. · 2002 · Recalled
- This deviceK103679 Axis Pacs, HMS PacsAxis Health Care, LLC · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −4 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −3 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −2 | K012211 | Efilm Workstation | Efilm Medical, Inc. | 2001 | 1 |
| −1 | K020995 | Efilm Workstation with Modules | Efilm Medical, Inc. | 2002 | 2 |
| 0 (this device) | K103679 | Axis Pacs, HMS Pacs | Axis Health Care, LLC | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 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 LLZ? 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 LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K020995 | Efilm Workstation with ModulesSummary page 1…e-Film Workstation with Modules Predicate"Device Manufacturer: Merge eFilm Medical, Inc. (Merge Healthcare) Predicate Device 510(k) Number: K(020995 Date Received: March 28, 2002 Decision Date: April 12, 2002 Decision:.… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- 2 of the 6 ancestors have a recall of any class.
- 14 other devices also cite its predicate K020995.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, 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 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
axis PACS is a software application intended to perform operations relating to acquisition, display, digital processing, review, transfer, archive, measurements, teleradiology exchange of medical images and patient demographic information, axis PACS receives digital images and data from various modalities, including but not limited to; Computed Radiography (CR), Computed Tomography (CT), Magnetic Resonance (MR), Ultrasound (US), Fluoroscopy (RF)…
Read the full statement (179 words)
axis PACS is a software application intended to perform operations relating to acquisition, display, digital processing, review, transfer, archive, measurements, teleradiology exchange of medical images and patient demographic information, axis PACS receives digital images and data from various modalities, including but not limited to; Computed Radiography (CR), Computed Tomography (CT), Magnetic Resonance (MR), Ultrasound (US), Fluoroscopy (RF), secondary screen captures devices, scanners, digitizers, or other imaging sources.
It is intended for use by the physician to aid diagnosis and used by medical professionals whenever they require access to medical images and patient demographic information. Users have access to a variety of measurement tools and imnageprocessing to aid them in viewing digital images.
This device may be used to archive mammography images (MG) but is not intended for primary diagnostic viewing of mammography images.
axis PACS can integrate with a health care institution's or physician's office Health Information System (HIS) or a Radiology Information System (RIS) for a fully integrated electronic patient record.
Typical users of axis PACS are trained medical professionals including radiologists, physicians, radiology technologists, and other clinicians.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103679 · printed Nov 5, 2026
Cite this page
510(k) Report. “K103679: Axis Pacs, HMS Pacs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K103679
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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