510(k) Report

510(k) · Cleared

Cleared

Modification to Gamma Guidance System

K983768510(k) TraditionalCleared Jul 2, 1999249-day reviewClass I21 CFR 892.1320

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

Radiation Monitoring Devices, Inc. · IZD Probe, Uptake, Nuclear

Cleared on Jul 2, 1999 as substantially equivalent to K961321 (Radiation Monitoring Devices, Inc., 1997) after a 249-day review. Its family tree reaches back 1 generation to 1997.

Decided
Jul 2, 1999
Review
249 days
Class
Class I
Product code
IZD
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K961321 (1997). No later device cites it as a predicate yet.

K961321 · Gamma Guidance System · Radiation Monitoring Devices, Inc. · 1997199619982000
K961321 · Gamma Guidance System · Radiation Monitoring Devices, Inc. · 19970
  1. Root · 1 generation backK961321 Gamma Guidance SystemRadiation Monitoring Devices, Inc. · 1997
  2. This deviceK983768 Modification to Gamma Guidance SystemRadiation Monitoring Devices, Inc. · 1999
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K961321Gamma Guidance SystemRadiation Monitoring Devices, Inc.1997—
0 (this device)K983768Modification to Gamma Guidance SystemRadiation Monitoring Devices, Inc.1999—
FIG. 1 — Lineage of K983768, 1997–1999Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 IZD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin 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
*K961321Gamma Guidance System
Summary page 1
…tion Monitoring Devices, Inc. 44 Hunt Street Watertown, MA 02172 Paul Stoppel October 23, 1998 Nuclear Uptake Probe Probe Not yet determined GAMMA GUIDANCE SYSTEM (K961321) The Modified GAMMA GUIDANCE SYSTEM is a portable battery powered system used for non-imaging procedures. It includes a hand-hel…
Radiation Monitoring Devices, Inc.1997—

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.

How does its category compare?

All IZD devices

IZD Probe, Uptake, Nuclear: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IZD

1in 2014

2011: 12013: 12014: 1
2007high 1 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IZD

Too few IZD 510(k)s in any year since 2007 to give a median.

Recalls per year · IZD

1in 2023

2018: 22020: 12023: 12026 (partial year): 1
2007high 2 (2018) · low 0 (2007)2026

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

Adverse event reports per year · IZD

8in 2025

2009: 22012: 12013: 32014: 12015: 12016: 12017: 62018: 42019: 32020: 12021: 12022: 32023: 62024: 72025: 8
2007high 8 (2025) · low 0 (2007)2025

MAUDE reports naming product code IZD, 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
20070—00
20080—00
20090—02
20100—00
20111—00
20120—01
20131—03
20141—01
20150—01
20160—01
20170—06
20180—24
20190—03
20200—11
20210—01
20220—03
20230—16
20240—07
20250—08
20260—1—

What is it indicated for?

For the detection and quantification of gamma radiation from gamma-emitting isotopes in the body or tissues. Use for non-imaging procedures to measure the amount of radionuclide absorbed by a particular organ or body region in open-surgical, laparoscopic or thoracoscopic surgical procedures.

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

More from Radiation Monitoring Devices, Inc.

2 FDA decisions under this applicant name. See the company

  • K961321Gamma Guidance SystemRadiation Monitoring Devices, Inc. · 1997

Recent decisions in IZD

The IZD category page

  • K133781Declipsespect LaparoscopySurgiceye GmbH · 2014
  • K123917Declipsespect ViewerSurgiceye GmbH · 2013
  • K101887Confident Surgery Suite 300, Model CSS300Surgiceye GmbH · 2011
  • K013751Handheld Gamma Finder (HGF)Silicon Instruments Gmhb · 2002
  • K982442C-Trak Automatic Analyzer (Name Change From Oncoprobe II to C-Trak)Care Wise Medical Products Corp. · 1998

https://510kreport.com/device/K983768 · printed Nov 4, 2026

Cite this page

510(k) Report. “K983768: Modification to Gamma Guidance System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983768

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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