510(k) · Cleared
Cleared10 X 10 Vision
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bioptics, Inc. · MWP Cabinet, X-Ray System
Cleared on Jun 16, 2010 as substantially equivalent to K021113 (Fischer Imaging Corp., 2002) after a 351-day review. Its family tree reaches back 1 generation to 2002.
- Decided
- Jun 16, 2010
- Review
- 351 days
- Class
- Class II
- Product code
- MWP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K021113 (2002). No later device cites it as a predicate yet.
- Root · 1 generation backK021113 MammopathFischer Imaging Corp. · 2002
- This deviceK091928 10 X 10 VisionBioptics, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K021113 | Mammopath | Fischer Imaging Corp. | 2002 | — |
| 0 (this device) | K091928 | 10 X 10 Vision | Bioptics, Inc. | 2010 | — |
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 MWP? 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 MWP device
- #1 K202713 TrueView 100 Proscore 7.9 · 6 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 |
|---|---|---|---|
| * | K021113 | MammopathSummary page 1…X 10 VISION, is substantially equivalent to the MammoPath® [registered trade mark of Fischer Imaging Technologies, Denver, Colorado- Stationary X-Ray System, K021113. B. DEVICE DESCRIPTON - as required by 807.92(a)(4) The 10 X 10 VISION will be marketed as a digital specimen… | 2002 |
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.
- 1 other device also cites its predicate K021113.
How does its category compare?
All MWP devicesMWP Cabinet, X-Ray System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · MWP
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · MWP
154in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MWP
No recall names MWP since 2007.
Adverse event reports per year · MWP
1in 2025
MAUDE reports naming product code MWP, 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 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 5 | 104 | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 4 | 154 | 0 | 3 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 2 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Bioiptics 10 X 10 VISION is a digital specimen radiography add-on upgrade to previously released cabinet x-ray systems. The 10 X 10 Vision is used for digital specimen radiography to provide rapid verification that the correct tissue has been excised during excisional or percutaneous biopsy. The 10 X 10 Vision is excluded from any use in in-vivo diagnostic or screening mammography applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091928 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091928: 10 X 10 Vision.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091928
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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