510(k) · Cleared
ClearedLorad 1-650 (International 650)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lorad Corp. · IZH System, X-Ray, Mammographic
Cleared on Sep 3, 1999 as substantially equivalent to K934870 (Lorad Corp., 1994) and 1 other predicate after a 58-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Sep 3, 1999
- Review
- 58 days
- Class
- Class II
- Product code
- IZH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K934870 (1994). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK934870 Lorad D-550Lorad Corp. · 1994
- This deviceK992280 Lorad 1-650 (International 650)Lorad Corp. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K934870 | Lorad D-550 | Lorad Corp. | 1994 | — |
| 0 (this device) | K992280 | Lorad 1-650 (International 650) | Lorad Corp. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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.
Planning a device in IZH? 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 IZH device
- #1 K202294 Affirm Contrast Biopsyscore 1.0 · 4 generations · no Class I recall
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 |
|---|---|---|---|
| * | K934870 | Lorad D-550Summary page 1…Mammography System Mammographic X-ray System 21 CFR 892.1710 Legally Marketed Device to Which Substantial Equivalence is Claimed: Lorad D-550 Mammographic X-ray System (K934870) and Lorad Elite Mammographic X-ray System (K973631). 7.3 Device Description 7.3.1 Intended Use The Lorad I-650 Mammography Sys… | 1994 |
| * | K973631 | Lorad M-Iii Elite (M-Iii E)Summary page 1…892.1710 Legally Marketed Device to Which Substantial Equivalence is Claimed: Lorad D-550 Mammographic X-ray System (K934870) and Lorad Elite Mammographic X-ray System (K973631). 7.3 Device Description 7.3.1 Intended Use The Lorad I-650 Mammography System is intended to produce radiographic images of th… | 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?
- None of the 2 ancestors has a recall.
How does its category compare?
All IZH devicesIZH System, X-Ray, Mammographic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IZH
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · IZH
64in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IZH
2in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IZH
15in 2025
MAUDE reports naming product code IZH, 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 | 3 | 30 | 0 | 11 |
| 2008 | 1 | — | 2 | 5 |
| 2009 | 0 | — | 0 | 14 |
| 2010 | 2 | — | 0 | 7 |
| 2011 | 1 | — | 0 | 5 |
| 2012 | 2 | — | 0 | 18 |
| 2013 | 2 | — | 0 | 9 |
| 2014 | 0 | — | 0 | 7 |
| 2015 | 1 | — | 0 | 8 |
| 2016 | 3 | 64 | 0 | 9 |
| 2017 | 0 | — | 0 | 12 |
| 2018 | 0 | — | 0 | 25 |
| 2019 | 1 | — | 0 | 39 |
| 2020 | 1 | — | 0 | 7 |
| 2021 | 1 | — | 0 | 9 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 8 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 15 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The 1-650 Mammography System is intended to produce radiographic images of the breast. Its specific intended use is for screening and diagnostic mammography. Screening mammography involves the production of images for initial examination for breast cancer diagnosis. Diagnostic mammography includes the production of magnified images for more thorough examination of areas of the breast determined suspicious through screening mammography, special views, spot compression views, and the production of images used by a physician in preparation for biopsy.
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/K992280 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992280: Lorad 1-650 (International 650).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992280
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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