510(k) · Cleared
ClearedProrad Atlas Ultraportable; Prorad Atlas Ultraportable Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Prognosys Medical Systems Private Limited · IZL System, X-Ray, Mobile
Cleared on Jul 29, 2025 as substantially equivalent to K212144 (Remedi Co., Ltd., 2021) after a 263-day review. Its family tree reaches back 4 generations to 2004.
- Decided
- Jul 29, 2025
- Review
- 263 days
- Class
- Class II
- Product code
- IZL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K040046 (2004). No later device cites it as a predicate yet.
- Root · 4 generations backK040046 Minxray, Model HF120/60H PowerplusMinxray, Inc. · 2004
- 3 generations backK153059 HF1202H PowerPlus Portable X-ray EquipmentMinxray, Inc. · 2016
- 2 generations backK182207 TR90BHMinxray, Inc. · 2018
- 1 generation backK212144 Remex KA6Remedi Co., Ltd. · 2021
- This deviceK243473 Prorad Atlas Ultraportable; Prorad Atlas Ultraportable PlusPrognosys Medical Systems Private Limited · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K040046 | Minxray, Model HF120/60H Powerplus | Minxray, Inc. | 2004 | — |
| −3 | K153059 | HF1202H PowerPlus Portable X-ray Equipment | Minxray, Inc. | 2016 | — |
| −2 | K182207 | TR90BH | Minxray, Inc. | 2018 | — |
| −1 | K212144 | Remex KA6 | Remedi Co., Ltd. | 2021 | — |
| 0 (this device) | K243473 | Prorad Atlas Ultraportable; Prorad Atlas Ultraportable Plus | Prognosys Medical Systems Private Limited | 2025 | — |
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 IZL? 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 IZL device
- #1 K242015 TOPAZ Mobile X-ray System (Models : TOPAZ-32D…score 19.9 · 19 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 |
|---|---|---|---|
| * | K212144 | Remex KA6Summary page 5…Regulation Number: 21 CFR 892.1720 Review Panel: Radiology Device Class: Class II Product Code: IZL Predicate Device: Remex KA6 (K212144) Device Description The PRORAD ATLAS X-Ray system includes the ULTRAPORTABLE and ULTRAPORTABLE PLUS, which are portable diagnost… | 2021 |
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 3 companies; a new generation was cleared every 4.0 years on median.
- None of the 4 ancestors has a recall.
- 2 other devices also cite its predicate K212144.
How does its category compare?
All IZL devicesIZL System, X-Ray, Mobile: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · IZL
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IZL
153in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IZL
47in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IZL
27in 2025
MAUDE reports naming product code IZL, 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 | 3 | 30 | 7 | 16 |
| 2008 | 4 | 49 | 0 | 27 |
| 2009 | 3 | 125 | 0 | 35 |
| 2010 | 3 | 65 | 4 | 75 |
| 2011 | 6 | 66 | 6 | 118 |
| 2012 | 3 | 83 | 5 | 24 |
| 2013 | 0 | — | 10 | 17 |
| 2014 | 7 | 104 | 4 | 51 |
| 2015 | 4 | 88 | 4 | 30 |
| 2016 | 6 | 47 | 0 | 33 |
| 2017 | 7 | 45 | 0 | 35 |
| 2018 | 8 | 47 | 0 | 27 |
| 2019 | 9 | 33 | 2 | 40 |
| 2020 | 9 | 43 | 1 | 48 |
| 2021 | 13 | 48 | 0 | 47 |
| 2022 | 16 | 89 | 1 | 32 |
| 2023 | 3 | 55 | 6 | 77 |
| 2024 | 9 | 159 | 5 | 39 |
| 2025 | 11 | 153 | 47 | 27 |
| 2026 | 6 | 157 | 5 | — |
What is it indicated for?
The PRORAD ATLAS ULTRAPORTABLE Digital X-ray system is intended to deliver high-quality, diagnostic radiographic images of the body extremities. It utilizes a portable X-ray unit, flat-panel detector and image acquisition software to produce clear digital images, enabling fast and accurate diagnosis. The portable X-ray unit is intended to be used only when stand/tripod mounted. The PRORAD ATLAS ULTRAPORTABLE X-ray digital system is predominantly employed…
Read the full statement (250 words)
The PRORAD ATLAS ULTRAPORTABLE Digital X-ray system is intended to deliver high-quality, diagnostic radiographic images of the body extremities. It utilizes a portable X-ray unit, flat-panel detector and image acquisition software to produce clear digital images, enabling fast and accurate diagnosis. The portable X-ray unit is intended to be used only when stand/tripod mounted.
The PRORAD ATLAS ULTRAPORTABLE X-ray digital system is predominantly employed in various settings, including health-care centres, temporary and emergency health centres (established, especially in pandemic circumstances), outreach and field interventions (such as mobile clinics/vans, screening campaigns, and home care), and tele-radiology solutions in remote areas.
The primary users anticipated for the system include radiographers, radiological technologists, and medical professionals who are trained in safety, radiation protection, and image management.
The PRORAD ATLAS ULTRAPORTABLE PLUS Digital X-ray system is intended to deliver high-quality, diagnostic radiographic images of the body extremities. It utilizes a portable X-ray Unit, flat-panel detector and real-time image processing using software to produce clear digital images, enabling fast and accurate diagnosis. The portable X-ray unit is intended to be used only when stand/tripod mounted.
The PRORAD ATLAS ULTRAPORTABLE PLUS X-ray digital system is predominantly employed in various settings, including health-care centres, temporary and emergency health centres (established, especially in pandemic circumstances), outreach and field interventions (such as mobile clinics/vans, screening campaigns, and home care), and tele-radiology solutions in remote areas.
The primary users anticipated for the system include radiographers, radiological technologists, and medical professionals who are trained in safety, radiation protection, and image management.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243473 · printed Nov 4, 2026
Cite this page
510(k) Report. “K243473: Prorad Atlas Ultraportable; Prorad Atlas Ultraportable Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K243473
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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