510(k) · Cleared
ClearedMca-601, C-Arm Mobile
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medison Radiology Systems, Inc. · JAA System, X-Ray, Fluoroscopic, Image-Intensified
Cleared on Mar 27, 2000 after a 132-day review. The FDA summary names no predicate by number. 15 later devices descend from it.
- Decided
- Mar 27, 2000
- Review
- 132 days
- Class
- Class II
- Product code
- JAA
- Recalls
- None
- Predicates
- 0
15 later devices descend from it, 1 citing it directly.
- This deviceK993896 Mca-601, C-Arm MobileMedison Radiology Systems, Inc. · 2000
- Descendant · cites it directly · 14 of its ownK032761 KMC-950 C-Arm Mobile SystemUnited Radiology Systems, Inc. · 2004
- Descendant · 2 generations on · 9 of its ownK160279 ANYVIEW-500R Fluoroscopic Mobile X-Ray SystemEcotron Co., Ltd. · 2016
- Descendant · 3 generations on · 7 of its ownK191503 MobileRay Pulse SE Digital Imaging SystemPortavision Medical, LLC · 2019
- Descendant · 4 generations on · 5 of its ownK211191 Virtual C DRF Digital Imaging SystemPortavision Medical, LLC · 2021
- Descendant · 5 generations on · 1 of its ownK241567 MC2 Portable X-ray SystemOxos Medical · 2024
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K032761KMC-950 C-Arm Mobile SystemUnited Radiology Systems, Inc. · 2004 · cites it directly14descendants
- K160279ANYVIEW-500R Fluoroscopic Mobile X-Ray SystemEcotron Co., Ltd. · 2016 · 2 generations on9descendants
- K191503MobileRay Pulse SE Digital Imaging SystemPortavision Medical, LLC · 2019 · 3 generations on7descendants
- K211191Virtual C DRF Digital Imaging SystemPortavision Medical, LLC · 2021 · 4 generations on5descendants
- K241567MC2 Portable X-ray SystemOxos Medical · 2024 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K993896 | Mca-601, C-Arm Mobile | Medison Radiology Systems, Inc. | 2000 | — |
| +1 | K032761 | KMC-950 C-Arm Mobile System | United Radiology Systems, Inc. | 2004 | — |
| +2 | K160279 | ANYVIEW-500R Fluoroscopic Mobile X-Ray System | Ecotron Co., Ltd. | 2016 | — |
| +3 | K191503 | MobileRay Pulse SE Digital Imaging System | Portavision Medical, LLC | 2019 | — |
| +4 | K211191 | Virtual C DRF Digital Imaging System | Portavision Medical, LLC | 2021 | — |
| +5 | K241567 | MC2 Portable X-ray System | Oxos Medical | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 4 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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.
Planning a device in JAA? 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 JAA device
- #1 K253103 Nexus DRF Digital X-ray Imaging Systemscore 13.2 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (15)
See all 151 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032761 | KMC-950 C-Arm Mobile System | 2004 | 14 |
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?
- Of its descendants, K032761 (United Radiology Systems, Inc., 2004) has gone furthest, with 14 descendants of its own.
How does its category compare?
All JAA devicesJAA System, X-Ray, Fluoroscopic, Image-Intensified: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JAA
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAA
89in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAA
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAA
33in 2025
MAUDE reports naming product code JAA, 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 | 1 | — | 35 | 9,517 |
| 2008 | 6 | 18 | 21 | 9,484 |
| 2009 | 0 | — | 18 | 12,040 |
| 2010 | 1 | — | 6 | 5,803 |
| 2011 | 4 | 48 | 7 | 14,000 |
| 2012 | 1 | — | 2 | 11,684 |
| 2013 | 6 | 129 | 3 | 13,706 |
| 2014 | 6 | 276 | 1 | 10,265 |
| 2015 | 3 | 197 | 1 | 2,922 |
| 2016 | 2 | — | 7 | 35 |
| 2017 | 1 | — | 3 | 56 |
| 2018 | 3 | 30 | 1 | 36 |
| 2019 | 6 | 49 | 2 | 49 |
| 2020 | 4 | 39 | 2 | 39 |
| 2021 | 6 | 104 | 2 | 35 |
| 2022 | 1 | — | 5 | 34 |
| 2023 | 2 | — | 9 | 41 |
| 2024 | 3 | 89 | 2 | 25 |
| 2025 | 2 | — | 4 | 33 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The MCA-601, C-Arm Moabile is used for providing fluoroscopic and
radiographic images of patient anatomy, especially during special procedures
in a hospital or medical clinics.
The fluoroscopic mode of operation is very useful to the attending physician
to see the images in real time without the need to develop individual films.
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/K993896 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993896: Mca-601, C-Arm Mobile.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993896
Report an extraction error
Are you the manufacturer?
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