510(k) · Cleared
ClearedPS 3000 Digatal Photospot System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Precise Optics · OWB Interventional Fluoroscopic X-Ray System
Cleared on Apr 7, 2003 as substantially equivalent to K963037 (Infimed, Inc., 1996) after a 90-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Apr 7, 2003
- Review
- 90 days
- Class
- Class II
- Product code
- OWB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K963037 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK963037 PatriotInfimed, Inc. · 1996
- This deviceK030061 PS 3000 Digatal Photospot SystemPrecise Optics · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K963037 | Patriot | Infimed, Inc. | 1996 | — |
| 0 (this device) | K030061 | PS 3000 Digatal Photospot System | Precise Optics | 2003 | — |
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 OWB? 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 OWB device
- #1 K251602 Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6…score 18.2 · 18 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 |
|---|---|---|---|
| * | K963037 | PatriotSummary page 2…ot System ™ is substantially equivalent to the performance of a an existing medical device: Patriot, now Gold One, manufactured by Infimed, Inc. of Liverpool, NY 13088 (K963037). The differences between these systems are incidental and not significant. Both devices use a similar technology and principles… | 1996 |
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.
- 3 other devices also cite its predicate K963037.
How does its category compare?
All OWB devicesOWB Interventional Fluoroscopic X-Ray System: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OWB
22in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OWB
148in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OWB
42so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OWB
14,008in 2025
MAUDE reports naming product code OWB, 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 | 52 | 0 | 1 |
| 2008 | 4 | 135 | 1 | 0 |
| 2009 | 9 | 99 | 0 | 0 |
| 2010 | 7 | 66 | 0 | 0 |
| 2011 | 6 | 79 | 0 | 1 |
| 2012 | 6 | 37 | 0 | 1 |
| 2013 | 11 | 119 | 10 | 27 |
| 2014 | 15 | 158 | 9 | 103 |
| 2015 | 11 | 66 | 35 | 2,134 |
| 2016 | 16 | 103 | 13 | 4,074 |
| 2017 | 20 | 76 | 13 | 1,604 |
| 2018 | 23 | 54 | 6 | 1,449 |
| 2019 | 9 | 174 | 7 | 1,558 |
| 2020 | 16 | 53 | 8 | 1,581 |
| 2021 | 24 | 60 | 31 | 1,981 |
| 2022 | 21 | 90 | 24 | 2,932 |
| 2023 | 12 | 152 | 22 | 7,604 |
| 2024 | 13 | 126 | 11 | 7,942 |
| 2025 | 22 | 148 | 30 | 14,008 |
| 2026 | 15 | 221 | 42 | — |
What is it indicated for?
The PS 3000 Digital PhotoSpot System ™ is a high resolution, digital imaging system designed for Digital Videography. It is intended to replace conventional film techniques in multipurpose or dedicated applications where general fluoroscopy, interventional fluoroscopy and angiography or cardiac imaging procedures are performed. The PS 3000 Digital PhotoSpot System ™ is indicated for use when it is necessary for a trained health care professional (for…
Read the full statement (109 words)
The PS 3000 Digital PhotoSpot System ™ is a high resolution, digital imaging system designed for
Digital Videography. It is intended to replace conventional film techniques in multipurpose or
dedicated applications where general fluoroscopy, interventional fluoroscopy and angiography or
cardiac imaging procedures are performed.
The PS 3000 Digital PhotoSpot System ™ is indicated for use when it is necessary for a trained health
care professional (for example an Radiologist) to acquire, record, review and distribute a digital image
from a x-ray image intensifiers in diagnostic imaging chains,
The PS 3000 Digital PhotoSpot System ™ is a prescription device. The labeling, instructions and user
operations are designed for trained 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/K030061 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030061: PS 3000 Digatal Photospot System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030061
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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