510(k) · Cleared
ClearedBiovision Digital Specimen Radiography System
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 Jul 17, 2009 as substantially equivalent to K052433 (Bioptics, Inc., 2005) after a 50-day review. Its family tree reaches back 2 generations to 2002. 7 later devices descend from it.
- Decided
- Jul 17, 2009
- Review
- 50 days
- Class
- Class II
- Product code
- MWP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K021113 (2002). 7 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK021113 MammopathFischer Imaging Corp. · 2002
- 1 generation backK052433 Pixarray 100 Digital Specimen Radiography (DSR) SystemBioptics, Inc. · 2005
- This deviceK091558 Biovision Digital Specimen Radiography SystemBioptics, Inc. · 2009
- Descendant · cites it directly · 4 of its ownK122428 Faxitron Specien Radiography SystemFaxitron Bioptics, LLC · 2012
- Descendant · cites it directly · 3 of its ownK153583 BioVision PlusFaxitron Bioptics, LLC · 2016
- Descendant · cites it directly · 2 of its ownK170786 Faxitron Bioptics Speciemen Radiography SystemFaxitron Bioptics, LLC · 2017
- Descendant · 2 generations on · 1 of its ownK173309 Faxitron VisionCTFaxitron Bioptics, LLC · 2018
- Descendant · cites it directly · 0 of its ownK213691 Solas ORCirdan Imaging, Ltd. · 2021
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K122428Faxitron Specien Radiography SystemFaxitron Bioptics, LLC · 2012 · cites it directly4descendants
- K153583BioVision PlusFaxitron Bioptics, LLC · 2016 · cites it directly3descendants
- K170786Faxitron Bioptics Speciemen Radiography SystemFaxitron Bioptics, LLC · 2017 · cites it directly2descendants
- K173309Faxitron VisionCTFaxitron Bioptics, LLC · 2018 · 2 generations on1descendant
- K213691Solas ORCirdan Imaging, Ltd. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K021113 | Mammopath | Fischer Imaging Corp. | 2002 | — |
| −1 | K052433 | Pixarray 100 Digital Specimen Radiography (DSR) System | Bioptics, Inc. | 2005 | — |
| 0 (this device) | K091558 | Biovision Digital Specimen Radiography System | Bioptics, Inc. | 2009 | — |
| +1 | K122428 | Faxitron Specien Radiography System | Faxitron Bioptics, LLC | 2012 | — |
| +1 | K153583 | BioVision Plus | Faxitron Bioptics, LLC | 2016 | — |
| +1 | K170786 | Faxitron Bioptics Speciemen Radiography System | Faxitron Bioptics, LLC | 2017 | — |
| +2 | K173309 | Faxitron VisionCT | Faxitron Bioptics, LLC | 2018 | — |
| +1 | K213691 | Solas OR | Cirdan Imaging, Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 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 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 |
|---|---|---|---|
| * | K052433 | Pixarray 100 Digital Specimen Radiography (DSR) SystemSummary page 1…stem is substantially equivalent to the piXarray 100 Digital Specimen Radiography System, manufactured by Bioptics, Inc. as a cabinet X-ray system, K052433. B. DEVICE DESCRIPTION - as required by 807.92(a)(4) The BioVision Digital Specimen Radiography (DSR) System… | 2005 |
What descends from it? (7)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 7 years and passes through 2 companies; a new generation was cleared every 3.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K122428 (Faxitron Bioptics, LLC, 2012) has gone furthest, with 4 descendants of its own.
- 3 other devices also cite its predicate K052433.
How does its category compare?
All MWP devicesMWP Cabinet, X-Ray System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 BioVision Digital Specimen Radiography (DSR) System is a cabinet digital X-ray imaging system intended to generate and control X-rays for examination of various anatomical regions, and to provide rapid verification that the correct tissue has beeh excised during excisional or percutaneous biopsy. Performing the verification directly in the same biopsy procedure room enables cases to be completed faster, thus limiting the time the patient needs to be…
Read the full statement (105 words)
The BioVision Digital Specimen Radiography (DSR) System is a cabinet digital X-ray imaging system intended to generate and control X-rays for examination of various anatomical regions, and to provide rapid verification that the correct tissue has beeh excised during excisional or percutaneous biopsy.
Performing the verification directly in the same biopsy procedure room enables cases to be completed faster, thus limiting the time the patient needs to be under examination. Specimen radiography can potentially limit the number of patient recalls. This device is intended to be operated wherever the medical professionals deem appropriate, including a surgical suite or a room adjacent to a surgical suite.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091558 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091558: Biovision Digital Specimen Radiography System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091558
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