510(k) · Cleared
ClearedConnect Imaging Pacs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Connect Imaging, Inc. · LLZ System, Image Processing, Radiological
Cleared on Sep 18, 2006 as substantially equivalent to K031704 (Connect Imaging, Inc., 2003) after a 67-day review. Its family tree reaches back 1 generation to 2003.
- Decided
- Sep 18, 2006
- Review
- 67 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K031704 (2003). No later device cites it as a predicate yet.
- Root · 1 generation backK031704 Filmless ClinicConnect Imaging, Inc. · 2003
- This deviceK061972 Connect Imaging PacsConnect Imaging, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K031704 | Filmless Clinic | Connect Imaging, Inc. | 2003 | — |
| 0 (this device) | K061972 | Connect Imaging Pacs | Connect Imaging, Inc. | 2006 | — |
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 LLZ? 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 LLZ device
- #1 K230955 syngo Application Softwarescore 21.6 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K031704 | Filmless ClinicSummary page 1…EM, IMAGE PROCESSING, RADIOLOGICAL Regulation Number: 892.2050 510(k) Number: K031704 Device Name: FilmLess Clinic Applicant: Connect Imaging Inc. Pr… | 2003 |
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 LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, 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 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
Connect Imaging PACS is a device intended to provide capability for the acceptance, transfer, display, storage, digitization and digital processing of medical images via the DICOM standard protocol. Options allow for additional capability, including transmission of images, digitization of film images, acceptance of digital images directly from different medical image modalities, and quality review of images. Lossy compressed mammographic images and…
Read the full statement (122 words)
Connect Imaging PACS is a device intended to provide capability for the acceptance, transfer, display, storage, digitization and digital processing of medical images via the DICOM standard protocol.
Options allow for additional capability, including transmission of images, digitization of film images, acceptance of digital images directly from different medical image modalities, and quality review of images.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specification reviewed and accepted by FDA.
Connect Imaging PACS is intended for use by qualified physicians and radiologists and other trained personnel such as technologists and nurses.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061972 · printed Nov 3, 2026
Cite this page
510(k) Report. “K061972: Connect Imaging Pacs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K061972
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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