510(k) Report

510(k) · Cleared

Cleared

Panther Ois/R & V Model Version 2.0

K122616510(k) TraditionalCleared Dec 21, 2012116-day reviewClass II21 CFR 892.5050

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

Prowess, Inc. · IYE Accelerator, Linear, Medical

Cleared on Dec 21, 2012 as substantially equivalent to K120067 (Impac Medical Systems, Inc., 2012) and 3 other predicates after a 116-day review. Its family tree reaches back 4 generations to 2000. 1 later device descends from it.

Decided
Dec 21, 2012
Review
116 days
Class
Class II
Product code
IYE
Recalls
None
Predicates
4

Its longest line of descent runs back 4 generations to K001643 (2000). 17 ancestors in all, the oldest K913612 (1991). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2012: 1 other ancestor2010: 1 other ancestor2009: 1 other ancestor2005: 1 other ancestor2004: 1 other ancestor2000: 1 other ancestor1998: 1 other ancestor1997: 2 other ancestors2001: 1 other ancestor1995: 2 other ancestors1991: 1 other ancestor2021: 1 descendant clearedK001643 · Varis 1.4G · Varian Medical Systems, Inc. · 2000 · recalledK050479 · 4D Integrated Treatment Console · Varian Medical Systems · 2005 · recalledK081036 · 4D Integrated Treatment Console with Patient Accessory Verification System (Pavs) · Varian Medical Systems, Inc. · 2008 · recalledK091132 · 4D Integrated Treatment Console · Varian Medical Systems · 2009 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 5 other ancestors3 generations back: 5 other ancestors 1 generation forward: 1 descendant K091132 · 4D Integrated Treatment Console · Varian Medical Systems · 2009 · recalledK081036 · 4D Integrated Treatment Console with Patient Accessory Verification System (Pavs) · Varian Medical Systems, Inc. · 2008 · recalledK050479 · 4D Integrated Treatment Console · Varian Medical Systems · 2005 · recalledK001643 · Varis 1.4G · Varian Medical Systems, Inc. · 2000 · recalled0
  1. Root · 4 generations backK001643 Varis 1.4GVarian Medical Systems, Inc. · 2000 · Recalled
  2. 3 generations backK050479 4D Integrated Treatment ConsoleVarian Medical Systems · 2005 · Recalled
  3. 2 generations backK081036 4D Integrated Treatment Console with Patient Accessory Verification…Varian Medical Systems, Inc. · 2008 · Recalled
  4. 1 generation backK091132 4D Integrated Treatment ConsoleVarian Medical Systems · 2009 · Recalled
  5. This deviceK122616 Panther Ois/R & V Model Version 2.0Prowess, Inc. · 2012
  6. Descendant · cites it directly · 0 of its ownK211760 Panther OISProwess, Inc. · 2021

Most influential descendants

Showing 1 of 1 · See all
  • K211760Panther OISProwess, Inc. · 2021 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K001643Varis 1.4GVarian Medical Systems, Inc.20008
−3K0504794D Integrated Treatment ConsoleVarian Medical Systems20052
−2K0810364D Integrated Treatment Console with Patient Accessory Verification System…Varian Medical Systems, Inc.20083
−1K0911324D Integrated Treatment ConsoleVarian Medical Systems20095
0 (this device)K122616Panther Ois/R & V Model Version 2.0Prowess, Inc.2012—
+1K211760Panther OISProwess, Inc.2021—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
199520
199720
199810
200010
200110
200410
200510
200910
201010
201210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202110
FIG. 1 — Lineage of K122616, 2000–2021Source: 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 IYE? 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 IYE device

  1. #1 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 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? (4)

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
*K120067Mosaiq Oncology Information System
Summary page 1
…Radiation Therapy Record and Verify System 3. Predicate Devices: a) IM PAC Medical Systems, Inc's (Elekta) MOSAIQ - K120067 b) Varian Medical System Inc.'s ARIA Radiation Oncology - K093527 c) Varian Medical System's 4D) Integrated Treat…
Impac Medical Systems, Inc.20123
*K093527Aria Radiation Oncology with Mirs
Summary page 1
…y System 3. Predicate Devices: a) IM PAC Medical Systems, Inc's (Elekta) MOSAIQ - K120067 b) Varian Medical System Inc.'s ARIA Radiation Oncology - K093527 c) Varian Medical System's 4D) Integrated Treatment Console (4DITC) - K091132 d) Prowess Inc's Puma (version 1.0)…
Varian Medical Systems, Inc.20099
*K0911324D Integrated Treatment Console
Summary page 1
…MOSAIQ - K120067 b) Varian Medical System Inc.'s ARIA Radiation Oncology - K093527 c) Varian Medical System's 4D) Integrated Treatment Console (4DITC) - K091132 d) Prowess Inc's Puma (version 1.0) -K100801 (*as previously cleared) 4. Device Description Panther 0151 R&V is med…
Varian Medical Systems20095
*K100801Puma Model Version 1.0
Summary page 1
…c.'s ARIA Radiation Oncology - K093527 c) Varian Medical System's 4D) Integrated Treatment Console (4DITC) - K091132 d) Prowess Inc's Puma (version 1.0) -K100801 (*as previously cleared) 4. Device Description Panther 0151 R&V is medical device software which allows the user to deliver…
Prowess, Inc.2010—

Also cleared against K120067: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K211760Panther OISProwess, Inc.20210

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 12 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
  • 8 of the 17 ancestors have a recall of any class.
  • Of its descendants, K211760 (Prowess, Inc., 2021) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K120067.

How does its category compare?

All IYE devices

IYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · IYE

12in 2025

2007: 232008: 142009: 202010: 232011: 112012: 282013: 182014: 202015: 202016: 212017: 232018: 212019: 192020: 202021: 192022: 122023: 182024: 92025: 122026 (partial year): 14
2007high 28 (2012) · low 9 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYE

170in 2025

2007: 44 days median2008: 69 days median2009: 63 days median2010: 74 days median2011: 94 days median2012: 106 days median2013: 88 days median2014: 100 days median2015: 108 days median2016: 97 days median2017: 94 days median2018: 58 days median2019: 83 days median2020: 67 days median2021: 86 days median2022: 172 days median2023: 129 days median2024: 239 days median2025: 170 days median2026 (partial year): 120 days median
2007high 239 (2024) · low 44 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · IYE

1in 2025

2007: 782008: 492009: 222010: 272011: 732012: 202013: 112014: 142015: 82016: 72017: 72018: 72019: 22020: 42021: 52022: 32023: 72024: 12025: 12026 (partial year): 4
2007high 78 (2007) · low 1 (2024)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · IYE

101in 2025

2007: 1552008: 1142009: 1742010: 2462011: 2802012: 1282013: 962014: 1242015: 1002016: 972017: 1252018: 852019: 912020: 742021: 682022: 662023: 1282024: 812025: 101
2007high 280 (2011) · low 66 (2022)2025

MAUDE reports naming product code IYE, 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
2007234478155
2008146949114
2009206322174
2010237427246
2011119473280
20122810620128
201318881196
20142010014124
2015201088100
20162197797
201723947125
20182158785
20191983291
20202067474
20211986568
202212172366
2023181297128
20249239181
2025121701101
2026141204—

What is it indicated for?

Panther oSR&V is an information management system used to manage medical data and clinical workflow in a hospital or clinic. To support radiation oncology users, it allowis the userto: * Enter or import, modify, store and archive treatment plans and images from treatment planning systems. * Import, view, manipulate, enhance, annotate, store, and archive radiological images. * Select and provide radiation treatment plans to a radiation treatment delivery…

Read the full statement (126 words)

Panther oSR&V is an information management system used to manage medical data and clinical workflow in a hospital or clinic. To support radiation oncology users, it allowis the userto:

* Enter or import, modify, store and archive treatment plans and images from treatment planning systems.

* Import, view, manipulate, enhance, annotate, store, and archive radiological images.

* Select and provide radiation treatment plans to a radiation treatment delivery system for patient treatment.

* Store and view treatment records provided by the radiation treatment delivery system.

* Monitor and track treatment progress.

* When Panther 0151 R&V is acting as an R&V system, verify the delivery device's settings against the planned parameters, record the treatment parameters settings and prevent treatment if the parameters are out of tolerance.

Indications for use as stated in the FDA summary.

Also cleared against K120067

1 other device cites the same predicate.

  • K142142Quality ReportsSun Nuclear Corporation · 2014

More from Prowess, Inc.

9 FDA decisions under this applicant name. See the company

  • K231825Panther TPSProwess, Inc. · 2023
  • K211760Panther OISProwess, Inc. · 2021
  • K193459Panther StereotacticProwess, Inc. · 2020
  • K143514Panther StereoSeedProwess, Inc. · 2015
  • K101076Prowess Panther Proarc, Model Version 5.0Prowess, Inc. · 2010

Recent decisions in IYE

The IYE category page

  • K261865AerFrame™ Alignment Laser Box (LBV2)Stabilix, LLC · 2026
  • K261718EZFluence (RADEZ V2)Radformation, Inc. · 2026
  • K260733MRIA Radiation Therapy Information System (MRIA)Manteia Technologies Co., Ltd. · 2026
  • K261856Halcyon, Ethos Radiotherapy System (5.0)Varian Medical Systems, Inc. · 2026
  • K252937ThinkQA 3Dosisoft SA · 2026

https://510kreport.com/device/K122616 · printed Nov 6, 2026

Cite this page

510(k) Report. “K122616: Panther Ois/R & V Model Version 2.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122616

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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