510(k) · Cleared
ClearedDiscovery NM 750b Bopsy
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GE Healthcare · IYX Camera, Scintillation (Gamma)
Cleared on Nov 18, 2016 as substantially equivalent to K102231 (Ge Medical Systems Israel, Functional Imaging, 2010) and 1 other predicate after a 228-day review. Its family tree reaches back 5 generations to 1995. 3 of the 15 devices in its family, counting itself, have a Class I recall.
- Decided
- Nov 18, 2016
- Review
- 228 days
- Class
- Class I
- Product code
- IYX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K952674 (1995). 14 ancestors in all, the oldest K885054 (1989). No later device cites it as a predicate yet. 3 of the 15 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK952674 Transact: Attenuation Correction System for the Apex Cardial Gamma…Elscint, Inc. · 1995 · Recalled
- 4 generations backK980959 Vtransact: Attenuation Correction System for Dual-Head Variable…Ge Medical Systems F.I. Haifa · 1998
- 3 generations backK991841 Hawkeye Option for Dual-Head Variable Angle Gamma CameraGe Medical Systems F.I. Haifa · 1999 · Recalled (Class I)
- 2 generations backK022960 GE Quasar Nuclear Medicine SystemGe Medical Systems F.I. Haifa · 2002 · Recalled (Class I)
- 1 generation backK102231 Discovery NM 750BGe Medical Systems Israel, Functional Imaging · 2010
- This deviceK160933 Discovery NM 750b BopsyGE Healthcare · 2016
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K952674 | Transact: Attenuation Correction System for the Apex Cardial Gamma Camera | Elscint, Inc. | 1995 | 1 |
| −4 | K980959 | Vtransact: Attenuation Correction System for Dual-Head Variable Angle Gamma… | Ge Medical Systems F.I. Haifa | 1998 | — |
| −3 | K991841 | Hawkeye Option for Dual-Head Variable Angle Gamma Camera | Ge Medical Systems F.I. Haifa | 1999 | Class I |
| −2 | K022960 | GE Quasar Nuclear Medicine System | Ge Medical Systems F.I. Haifa | 2002 | Class I |
| −1 | K102231 | Discovery NM 750B | Ge Medical Systems Israel, Functional Imaging | 2010 | — |
| 0 (this device) | K160933 | Discovery NM 750b Bopsy | GE Healthcare | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 1 |
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2009 | 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.
3 devices in this family have a Class I recall. 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 IYX device
- #1 K230221 QDOSE® Multi-purpose Voxel Dosimetry…score 6.2 · 2 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K102231 | Discovery NM 750BSummary page 4…50b Biopsy system Classification Names 21CFR 892.1100 Device Classification Class I Product Code: 90 IYX Predicate Device(s): Discovery NM 750b (K102231), GammaLoc System (K082588) Reference Device: Senographe Stereo (K040125)… | 2010 |
| * | K082588 | Gammaloc System, Model 03-00001Summary page 4…ication Names 21CFR 892.1100 Device Classification Class I Product Code: 90 IYX Predicate Device(s): Discovery NM 750b (K102231), GammaLoc System (K082588) Reference Device: Senographe Stereo (K040125) 5-2 GE He… | 2009 |
| † | K040125 | Senographic Stereo | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K022960GE Quasar Nuclear Medicine SystemGe Medical Systems F.I. Haifa · 2002 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K991841Hawkeye Option for Dual-Head Variable Angle Gamma CameraGe Medical Systems F.I. Haifa · 1999 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K953801VaricamElscint, Inc. · 1995 · 3 generations back · ◆ in the 1995 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 3.1 years on median.
- 4 of the 14 ancestors have a recall of any class; 3 have a Class I recall.
- 1 other device also cites its predicate K102231.
How does its category compare?
All IYX devicesIYX Camera, Scintillation (Gamma): FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · IYX
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · IYX
82in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYX
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYX
1in 2022
MAUDE reports naming product code IYX, 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 | 11 |
| 2008 | 2 | — | 0 | 10 |
| 2009 | 2 | — | 0 | 8 |
| 2010 | 4 | 82 | 0 | 5 |
| 2011 | 3 | 82 | 0 | 6 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 4 |
| 2016 | 2 | — | 0 | 2 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 2 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Discovery NM 750b Gamma Camera is intended to measure and image the distribution of selected single photon emission radioisotopes in the human body to aid in the evaluation of lesions. The resultant images are intended to be reviewed by qualified medical professionals. The Discovery NM 750b Gamma Camera is intended for diagnostic imaging of the breast and other small body parts. The Discovery NM 750b Gamma Camera when used for breast imaging is…
Read the full statement (178 words)
The Discovery NM 750b Gamma Camera is intended to measure and image the distribution of selected single photon emission radioisotopes in the human body to aid in the evaluation of lesions. The resultant images are intended to be reviewed by qualified medical professionals. The Discovery NM 750b Gamma Camera is intended for diagnostic imaging of the breast and other small body parts. The Discovery NM 750b Gamma Camera when used for breast imaging is intended as an adjunct to mammography or other breast imaging modalities (it is not intended for primary screening of the population). The Discovery NM 750b Gamma Camera is indicated for planar and dynamic planar scintigraphy in the energy range 80-200keV for the detection and display of radioisotope tracer uptake in patients of all ages.
When used with the optional Discovery NM 750b Biopsy system, the Discovery NM 750b is designed to accurately locate, in three dimensions, lesions in the breast using information derived from stereotactic pairs of two-dimensional images. It is intended to provide guidance for interventional purposes such as biopsy and pre-surgical localization.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K160933 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160933: Discovery NM 750b Bopsy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160933
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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