510(k) Report

510(k) · Cleared

Cleared

Transview (Transmission System),Model NDTR-701A

K982300510(k) TraditionalCleared Sep 25, 199886-day reviewClass II21 CFR 892.1200

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

Toshiba America Medical Systems, In.C · KPS System, Tomography, Computed, Emission

Cleared on Sep 25, 1998 as substantially equivalent to K943596 (Adac Laboratories, 1995) and 3 other predicates after an 86-day review. Its family tree reaches back 1 generation to 1995.

Decided
Sep 25, 1998
Review
86 days
Class
Class II
Product code
KPS
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to K943596 (1995). 4 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1997: 1 other ancestor1996: 1 other ancestor1995: 1 other ancestorK943596 · Vantage, for Adac Gamma Cameras · Adac Laboratories · 1995199619982000
Other ancestors, by generation 1 generation back: 3 other ancestors K943596 · Vantage, for Adac Gamma Cameras · Adac Laboratories · 19950
  1. Root · 1 generation backK943596 Vantage, for Adac Gamma CamerasAdac Laboratories · 1995
  2. This deviceK982300 Transview (Transmission System),Model NDTR-701AToshiba America Medical Systems, In.C · 1998
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K943596Vantage, for Adac Gamma CamerasAdac Laboratories1995—
0 (this device)K982300Transview (Transmission System),Model NDTR-701AToshiba America Medical Systems, In.C1998—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
199610
199710
FIG. 1 — Lineage of K982300, 1995–1998Source: 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 KPS? 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 KPS device

  1. #1 K253564 uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI…score 18.6 · 17 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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
*K943596Vantage, for Adac Gamma Cameras
Summary page 1
…ification Nanre: - Emission Computed Tomography System Common Name: Gamma Camera Option , [Fed. Reg. No. 892.1200, Pro. Code: 90 KPS] Predicate Devices: ADAC Vantage (K943596), Picker STEP 2000 Option (K960865), Siemens E CAM Profile (K963983), and Elscint TransACT (K952674) Reason for Submission New o…
Adac Laboratories1995—
*K960865Step Option to Prism 2000
Summary page 1
…d Tomography System Common Name: Gamma Camera Option , [Fed. Reg. No. 892.1200, Pro. Code: 90 KPS] Predicate Devices: ADAC Vantage (K943596), Picker STEP 2000 Option (K960865), Siemens E CAM Profile (K963983), and Elscint TransACT (K952674) Reason for Submission New option for existing product Descrip…
Philips Medical Systems (Cleveland), Inc.1996—
*K963983E. Cam Profile Attenuation Correction
Summary page 1
…Gamma Camera Option , [Fed. Reg. No. 892.1200, Pro. Code: 90 KPS] Predicate Devices: ADAC Vantage (K943596), Picker STEP 2000 Option (K960865), Siemens E CAM Profile (K963983), and Elscint TransACT (K952674) Reason for Submission New option for existing product Description of this Device: The TRANSVI…
Siemens Corp.1997—
*K952674Transact: Attenuation Correction System for the Apex Cardial Gamma Camera
Summary page 1
…g. No. 892.1200, Pro. Code: 90 KPS] Predicate Devices: ADAC Vantage (K943596), Picker STEP 2000 Option (K960865), Siemens E CAM Profile (K963983), and Elscint TransACT (K952674) Reason for Submission New option for existing product Description of this Device: The TRANSVIEW (Transmission system), model…
Elscint, Inc.19951

Also cleared against K943596: 1 other device →

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?

  • 1 of the 4 ancestors has a recall of any class.
  • 1 other device also cites its predicate K943596.

How does its category compare?

All KPS devices

KPS System, Tomography, Computed, Emission: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KPS

12in 2025

2007: 82008: 172009: 92010: 32011: 72012: 62013: 112014: 112015: 32016: 112017: 112018: 132019: 32020: 122021: 152022: 52023: 122024: 112025: 122026 (partial year): 6
2007high 17 (2008) · low 3 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KPS

65in 2025

2007: 38 days median2008: 25 days median2009: 42 days median2010: 91 days median2011: 28 days median2012: 94 days median2013: 84 days median2014: 92 days median2015: 112 days median2016: 65 days median2017: 104 days median2018: 59 days median2019: 60 days median2020: 72 days median2021: 66 days median2022: 60 days median2023: 63 days median2024: 59 days median2025: 65 days median2026 (partial year): 67 days median
2007high 112 (2015) · low 25 (2008)2026

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

Recalls per year · KPS

16in 2025

2007: 222008: 162009: 142010: 42011: 342012: 132013: 132014: 182015: 52016: 162017: 112018: 12, 3 Class I2019: 5, 5 Class I2020: 82021: 42022: 8, 6 Class I2023: 6, 3 Class I2024: 152025: 162026 (partial year): 6
2007high 34 (2011) · low 4 (2010)2026

Class I (17 since 2007) Class II/III not classified

Adverse event reports per year · KPS

36in 2025

2007: 382008: 112009: 152010: 442011: 562012: 342013: 2402014: 332015: 242016: 102017: 312018: 262019: 1052020: 222021: 102022: 152023: 222024: 232025: 36
2007high 240 (2013) · low 10 (2016)2025

MAUDE reports naming product code KPS, 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
20078382238
200817251611
20099421415
2010391444
20117283456
20126941334
2013118413240
201411921833
20153112524
201611651610
2017111041131
2018135912 (3)26
20193605 (5)105
20201272822
20211566410
20225608 (6)15
202312636 (3)22
202411591523
202512651636
20266676—

What is it indicated for?

To detect or image the distribution of radionuclides in the body or organ, using the following technique(s).

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K943596

1 other device cites the same predicate.

  • K971878Vantage 2.1 ExspectAdac Laboratories · 1997

More from Toshiba America Medical Systems, In.C

146 FDA decisions under this applicant name. See the company

  • K141472Vantage ElanToshiba America Medical Systems, In.C · 2014
  • K133553KalareToshiba America Medical Systems, In.C · 20143 recalls
  • K140729Aplio Artida, V3.2Toshiba America Medical Systems, In.C · 2014
  • K132106Infinix Angio Workstation W/DTS SoftwareToshiba America Medical Systems, In.C · 2013
  • K131822Ultraextend Usws-900A V2.1 and V3.1Toshiba America Medical Systems, In.C · 2013

Recent decisions in KPS

The KPS category page

  • K261305Micsi-PetMicrostructure Imaging, Inc. · 2026
  • K261427uMI Panvivo (uMI Panvivo M)Shanghai United Imaging Healthcare Co., Ltd. · 2026
  • K261315Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia…Siemens Medical Solutions USA, Inc. · 2026
  • K260524uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI…Shanghai United Imaging Healthcare Co., Ltd. · 2026
  • K253564uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI…Shanghai United Imaging Healthcare Co., Ltd. · 2026

https://510kreport.com/device/K982300 · printed Nov 4, 2026

Cite this page

510(k) Report. “K982300: Transview (Transmission System),Model NDTR-701A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982300

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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