510(k) · Cleared
ClearedArripro 35 ST/TV
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arnold & Richter Cine Technik · IXC Illuminator, Radiographic-Film
Cleared on Sep 2, 1997 as substantially equivalent to K971128 (Jamieson Film Co., 1997) after a 13-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Sep 2, 1997
- Review
- 13 days
- Class
- Class I
- Product code
- IXC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K971128 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK971128 Cap-35B Iii/Cine 275Jamieson Film Co. · 1997
- This deviceK973115 Arripro 35 ST/TVArnold & Richter Cine Technik · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K971128 | Cap-35B Iii/Cine 275 | Jamieson Film Co. | 1997 | — |
| 0 (this device) | K973115 | Arripro 35 ST/TV | Arnold & Richter Cine Technik | 1997 | — |
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 IXC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K971128 | Cap-35B Iii/Cine 275Summary page 1…ntended to be used for the projection, diagnosis and quantitative evaluation of 35 mm cineradiographic images CAP 35BIl / CINE 275 - Cineangiogram projector Class Il K 971128 DIN-Standards applied for the Arripro 35 St/TV 1. DIN 6856, Part 1 Demands for the manufacture and the operation of viewing ap… | 1997 |
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?
- Its one ancestor has no recall.
How does its category compare?
All IXC devicesIXC Illuminator, Radiographic-Film: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IXC
FDA has decided no IXC device since 2007.
Median 510(k) review, days · IXC
Too few IXC 510(k)s in any year since 2007 to give a median.
Recalls per year · IXC
No recall names IXC since 2007.
Adverse event reports per year · IXC
No MAUDE report names IXC 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 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The device is used for the diagnosis and quantitative evaluation of 35 mm cine radiographic images, which originating from radiographic imaging like Angiography.
The device contains a visible light source covered with a translucent front that is intended to be used to view medical cine radiographic images (CFR 21 part 892.1890). It also allows to be used for wall projection. The medical device is not part of a diagnostic x-ray system.
The device may only be operated in cathlabs, lecture halls and doctors’ consulting rooms. The device is only for use by medical professionals.
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/K973115 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973115: Arripro 35 ST/TV.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973115
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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