510(k) Report

510(k) · Cleared

Cleared

Pixarray 100 Digital Specimen Radiography (DSR) System

K052433510(k) TraditionalCleared Oct 18, 200542-day reviewClass II21 CFR 892.1680

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Bioptics, Inc. · MWP Cabinet, X-Ray System

Cleared on Oct 18, 2005 as substantially equivalent to K021113 (Fischer Imaging Corp., 2002) after a 42-day review. Its family tree reaches back 1 generation to 2002. 25 later devices descend from it.

Decided
Oct 18, 2005
Review
42 days
Class
Class II
Product code
MWP
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K021113 (2002). 25 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2007: 2 descendants cleared2008: 1 descendant cleared2009: 2 descendants cleared2021: 4 descendants cleared2019: 5 descendants cleared2020: 2 descendants cleared2018: 1 descendant cleared2012: 1 descendant cleared2016: 1 descendant cleared2017: 2 descendants cleared2011: 1 descendant cleared2026: 1 descendant cleared2023: 2 descendants clearedK021113 · Mammopath · Fischer Imaging Corp. · 2002200020052010201520202025
Descendants, by generation 1 generation forward: 4 descendants2 generations forward: 10 descendants3 generations forward: 5 descendants4 generations forward: 2 descendants5 generations forward: 2 descendants6 generations forward: 2 descendants K021113 · Mammopath · Fischer Imaging Corp. · 20020+5
  1. Root · 1 generation backK021113 MammopathFischer Imaging Corp. · 2002
  2. This deviceK052433 Pixarray 100 Digital Specimen Radiography (DSR) SystemBioptics, Inc. · 2005
  3. Descendant · cites it directly · 18 of its ownK071233 Xpert 40 Specimen Radiography SystemKub Technologies, Inc. · 2007
  4. Descendant · 2 generations on · 15 of its ownK083510 Kubtec Xpert 20Kub Technologies, Inc. · 2009
  5. Descendant · 3 generations on · 14 of its ownK111508 Trident Specimen Radiography System, Model : RC Tri-00001Hologic, Inc. · 2011
  6. Descendant · cites it directly · 7 of its ownK091558 Biovision Digital Specimen Radiography SystemBioptics, Inc. · 2009
  7. Descendant · cites it directly · 5 of its ownK072557 Faxitron Specimen Radiography System, Model MX-20Faxitron X-Ray Corp. · 2007

Showing 5 of 25 descendants. See all descendants

Descendants cleared per year

2007: 22008: 12009: 22011: 12012: 12016: 12017: 22018: 12019: 52020: 22021: 42023: 22026: 1
2007high 5 (2019) · low 0 (2010)2026

Most influential descendants

Showing 5 of 25 · See all
  • K071233Xpert 40 Specimen Radiography SystemKub Technologies, Inc. · 2007 · cites it directly18descendants
  • K083510Kubtec Xpert 20Kub Technologies, Inc. · 2009 · 2 generations on15descendants
  • K111508Trident Specimen Radiography System, Model : RC Tri-00001Hologic, Inc. · 2011 · 3 generations on14descendants
  • K091558Biovision Digital Specimen Radiography SystemBioptics, Inc. · 2009 · cites it directly7descendants
  • K072557Faxitron Specimen Radiography System, Model MX-20Faxitron X-Ray Corp. · 2007 · cites it directly5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K021113MammopathFischer Imaging Corp.2002—
0 (this device)K052433Pixarray 100 Digital Specimen Radiography (DSR) SystemBioptics, Inc.2005—
+1K071233Xpert 40 Specimen Radiography SystemKub Technologies, Inc.2007—
+2K083510Kubtec Xpert 20Kub Technologies, Inc.2009—
+3K111508Trident Specimen Radiography System, Model : RC Tri-00001Hologic, Inc.2011—
+1K091558Biovision Digital Specimen Radiography SystemBioptics, Inc.2009—
+1K072557Faxitron Specimen Radiography System, Model MX-20Faxitron X-Ray Corp.2007—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200720
200810
200920
201110
201210
201610
201720
201810
201950
202020
202140
202320
202610
FIG. 1 — Lineage of K052433, 2002–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K202713 TrueView 100 Proscore 7.9 · 6 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K021113Mammopath
Summary page 1
…raphy (I)SR) System is substantially equivalent to the Mammopath' m [trade mark of Fischer Imaging Corporation. Denver, Colorado] cabinet X-ray system. K021113. B. DEVICE DESCRIPTION - as required by 807.92(a)(4) Ihe piXarray 100 Digital Specimen Radiography (D)SR) Syste…
Fischer Imaging Corp.2002—

Also cleared against K021113: 1 other device →

What descends from it? (25)

See all 25

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K071233Xpert 40 Specimen Radiography SystemKub Technologies, Inc.200718
K091558Biovision Digital Specimen Radiography SystemBioptics, Inc.20097
K072557Faxitron Specimen Radiography System, Model MX-20Faxitron X-Ray Corp.20075
K082432Core Vision Digital Specimen Radiography (DSR) SystemBioptics, Inc.20081

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.
  • Of its descendants, K071233 (Kub Technologies, Inc., 2007) has gone furthest, with 18 descendants of its own.
  • 1 other device also cites its predicate K021113.

How does its category compare?

All MWP devices

MWP Cabinet, X-Ray System: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MWP

2in 2023

2007: 22008: 12009: 12010: 12011: 12012: 12016: 12017: 12018: 12019: 52020: 22021: 42023: 2
2007high 5 (2019) · low 0 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MWP

154in 2021

2019: 104 days median2021: 154 days median
2007high 154 (2021) · low 104 (2019)2026

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

2018: 12021: 32022: 12023: 32024: 12025: 1
2007high 3 (2021) · low 0 (2007)2025

MAUDE reports naming product code MWP, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—00
20081—00
20091—00
20101—00
20111—00
20121—00
20130—00
20140—00
20150—00
20161—00
20171—00
20181—01
2019510400
20202—00
2021415403
20220—01
20232—03
20240—01
20250—01
20260—0—

What is it indicated for?

The piXarray 100 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 been 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…

Read the full statement (106 words)

The piXarray 100 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 been 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.

Also cleared against K021113

1 other device cites the same predicate.

  • K09192810 X 10 VisionBioptics, Inc. · 2010

More from Bioptics, Inc.

4 FDA decisions under this applicant name. See the company

  • K09192810 X 10 VisionBioptics, Inc. · 2010
  • K091558Biovision Digital Specimen Radiography SystemBioptics, Inc. · 2009
  • K082432Core Vision Digital Specimen Radiography (DSR) SystemBioptics, Inc. · 2008

Recent decisions in MWP

The MWP category page

  • K230140TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US)Compai Healthcare (Suzhou) Co.,Ltd · 2023
  • K230136TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US)Compai Healthcare (Suzhou) Co.,Ltd · 2023
  • K213691Solas ORCirdan Imaging, Ltd. · 2021
  • K210955Kubtec Mozart Supra (XPERT 84) Radiography SystemKub Technologies, Inc. · 2021
  • K210957Kubec Xpert 80 Radiography SystemKub Technologies, Inc. · 2021

https://510kreport.com/device/K052433 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052433: Pixarray 100 Digital Specimen Radiography (DSR) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052433

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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