510(k) · Cleared
ClearedAview RT Acs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coreline Soft Co., Ltd. · QKB Radiological Image Processing Software For Radiation Therapy
Cleared on Nov 10, 2022 as substantially equivalent to K182624 (Mim Software, Inc., 2018) after a 269-day review. Its family tree reaches back 14 generations to 1996. 1 of the 101 devices in its family, counting itself, has a Class I recall.
- Decided
- Nov 10, 2022
- Review
- 269 days
- Class
- Class II
- Product code
- QKB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K954874 (1996). 100 ancestors in all, the oldest K885054 (1989). No later device cites it as a predicate yet. 1 of the 101 devices in this family, counting this one, has a Class I recall.
- Root · 14 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 10 generations between
- 3 generations backK172218 MIM – Y90 DosimetryMim Software, Inc. · 2017
- 2 generations backK180815 MIM - SPECTRA QuantMim Software, Inc. · 2018
- 1 generation backK182624 MIM - MRT DosimetryMim Software, Inc. · 2018
- This deviceK220408 Aview RT AcsCoreline Soft Co., Ltd. · 2022
Show all 14 generations
- Root · 14 generations backK954874 Spectef ProtocolGE Medical Systems · 1996
- 13 generations backK980914 Emory Cardiac Tool BoxEmory University · 1998
- 12 generations backK992450 Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine ComputersEmory University · 1999
- 11 generations backK014033 Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine ComputersSyntermed, Inc. · 2002
- 10 generations backK040141 Emory Cardiac Toolbox Version 2.6Syntermed, Inc. · 2004
- 9 generations backK052379 Mim 3.5 (Circa)Mimvista Corp. · 2005
- 8 generations backK060816 Mim 4.0 (NeuroMimvista Corp. · 2006 · Recalled
- 7 generations backK062163 MimviewerMimvista Corp. · 2006
- 6 generations backK103785 Mobile MimMim Software, Inc. · 2011
- 5 generations backK112930 Mobile MimMim Software, Inc. · 2011
- 4 generations backK151913 MIM-Thin Client (mobile)Mim Software, Inc. · 2016
- 3 generations backK172218 MIM – Y90 DosimetryMim Software, Inc. · 2017
- 2 generations backK180815 MIM - SPECTRA QuantMim Software, Inc. · 2018
- 1 generation backK182624 MIM - MRT DosimetryMim Software, Inc. · 2018
- This deviceK220408 Aview RT AcsCoreline Soft Co., Ltd. · 2022
Class I recalls in this family
- K991841 Hawkeye Option for Dual-Head Variable Angle…4 generations back · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K954874 | Spectef Protocol | GE Medical Systems | 1996 | — |
| −13 | K980914 | Emory Cardiac Tool Box | Emory University | 1998 | — |
| −12 | K992450 | Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine Computers | Emory University | 1999 | — |
| −11 | K014033 | Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine Computers | Syntermed, Inc. | 2002 | — |
| −10 | K040141 | Emory Cardiac Toolbox Version 2.6 | Syntermed, Inc. | 2004 | — |
| −9 | K052379 | Mim 3.5 (Circa) | Mimvista Corp. | 2005 | — |
| −8 | K060816 | Mim 4.0 (Neuro | Mimvista Corp. | 2006 | 1 |
| −7 | K062163 | Mimviewer | Mimvista Corp. | 2006 | — |
| −6 | K103785 | Mobile Mim | Mim Software, Inc. | 2011 | — |
| −5 | K112930 | Mobile Mim | Mim Software, Inc. | 2011 | — |
| −4 | K151913 | MIM-Thin Client (mobile) | Mim Software, Inc. | 2016 | — |
| −3 | K172218 | MIM – Y90 Dosimetry | Mim Software, Inc. | 2017 | — |
| −2 | K180815 | MIM - SPECTRA Quant | Mim Software, Inc. | 2018 | — |
| −1 | K182624 | MIM - MRT Dosimetry | Mim Software, Inc. | 2018 | — |
| 0 (this device) | K220408 | Aview RT Acs | Coreline Soft Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 5 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 5 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 1 |
| 2000 | 9 | 0 |
| 2001 | 6 | 0 |
| 2002 | 6 | 0 |
| 2003 | 5 | 0 |
| 2004 | 7 | 0 |
| 2005 | 5 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 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 QKB device
- #1 K191928 AccuContourscore 32.8 · 14 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 |
|---|---|---|---|
| * | K182624 | MIM - MRT DosimetrySummary page 4…ical Image Processing Software For Radiation Therapy (21CFR 892.2050) Regulatory Class: 11 Product Code: QKB 3 PREDICATE DEVICE MIM-MRT Dosimetry by MIM Software Inc. (K182624) Name of Device: MIM-MRT Dosimetry Common or Usual Name: Medical Imaging Software Classification Name: System, image processin… | 2018 |
| † | K191928 | AccuContour | 2020 |
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 · 4 generations back · ◆ in the 1999 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 26 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
- 31 of the 100 ancestors have a recall of any class; 1 has a Class I recall.
- 4 other devices also cite its predicate K182624.
How does its category compare?
All QKB devicesQKB Radiological Image Processing Software For Radiation Therapy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · QKB
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QKB
170in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QKB
No recall names QKB since 2007.
Adverse event reports per year · QKB
No MAUDE report names QKB since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 4 | 244 | 0 | 0 |
| 2021 | 9 | 120 | 0 | 0 |
| 2022 | 7 | 162 | 0 | 0 |
| 2023 | 7 | 111 | 0 | 0 |
| 2024 | 6 | 173 | 0 | 0 |
| 2025 | 6 | 170 | 0 | 0 |
| 2026 | 9 | 179 | 0 | — |
What is it indicated for?
AVIEW RT ACS provides deep-learning-based auto-segmented organs and generates contours in RT-DICOM format from CT images which could be used as an initial contour for the clinicians to approve and edit by the radiation oncology department for treatment planning or other professions where a segmented mask of organs is needed. a. Deep learning contouring from four body parts (Head & Neck, Breast, Abdomen, and Pelvis) b. Generates RT-DICOM structure of…
Read the full statement (133 words)
AVIEW RT ACS provides deep-learning-based auto-segmented organs and generates contours in RT-DICOM format from CT images which could be used as an initial contour for the clinicians to approve and edit by the radiation oncology department for treatment planning or other professions where a segmented mask of organs is needed.
a. Deep learning contouring from four body parts (Head & Neck, Breast, Abdomen, and Pelvis)
b. Generates RT-DICOM structure of contoured organs
c. Rule-based auto pre-processing
Receive/Send/Export medical images and DICOM data
Note that the Breast (Both right and left lung, Heart) were validated with non-contrast and contrast CT. Head & Neck (Both right and left Eyes, Brain and Mandible), Abdomen (Both right and left Kidney and Liver), and Pelvis (Both right and left Femur and Bladder) were validated with Contrast CT only.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K220408 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220408: Aview RT Acs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220408
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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