3600
The iCR 3600M is a digital mammography computed radiography (CR) scanner manufactured by iCRco. It utilizes True Flat Scan Path technology to read phosphor plates without rollers, paired…
The iCR 3600M is a digital mammography computed radiography (CR) scanner manufactured by iCRco. It utilizes True Flat Scan Path technology to read phosphor plates without rollers, paired with ICE-M image processing algorithms designed specifically for mammography in addition to general radiography application
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Fujifilm Imaging System (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 3 |
Record
| Listed by | iCRco Inc., United States |
|---|---|
| FDA product code | MUE |
| Device type | Full Field Digital, System, X-Ray, Mammographic |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1715 |
| Establishment | Repacker / relabeller, Manufacturer |
| Record published | 2026-07-22 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Distribution end date | 2030-01-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Selenia® Dimensions® | Hologic, Inc. | 47 |
| Selenia Ffdm | Hologic, Inc. | 29 |
| Full Field Digital, System, X-Ray, Mammographic | GE Medical Systems, LLC | 10 |
| Senographe Pristina | GE Medical Systems, LLC | 10 |
| Directview CR Mammography Cassette with EHR-M Screen | Carestream Health, Inc. | 10 |
| Giotto Class | IMS Giotto SPA | 6 |
| Directview CR Mammography Cassette with EHR-M3 Screen | Carestream Health, Inc. | 5 |
| Giotto Image 3DL | I.M.S. Internazionale Medico Scientifica SRL | 5 |
| CR-IR 392 | Fujifilm Corporation | 3 |
| Giotto Image | IMS Giotto SPA | 3 |
| CR HD5.0 AEC Cassette | Agfa Healthcare Inc. | 3 |
| Directview CR Mammography Cassette with HR Screen | Carestream Health, Inc. | 3 |
Showing 12 of 103. All products under Full Field Digital, System, X-Ray, Mammographic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K122510 | 2013-04-26 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P080018 | 2010-11-03 | KODAK DIRECTVIEW COMPUTED RADIOGRAPHY (CR) MAMMOGRAPHY | Carestream Health, Inc. |
| P050014 | 2009-01-09 | FUJI COMPUTED RADIOGRAPHY MAMMOGRAPHY SUITE | Fujifilm Medical System U.S.A., Inc. |
| P990066 | 2007-08-01 | GE SENOGRAPHE ESSENTIAL FULL FIELD MAMMOGRAPHY SYSYTEM (SENO ESSENTIAL | GE Healthcare GmbH |
| P030010 | 2004-08-20 | SIEMENS MAMMOMAT NOVATIONDR FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM | Siemens Medical Solution |
| P010017 | 2004-05-12 | SENOSCAN FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM | Hologic, Inc. |
| P010025 | 2003-09-24 | SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM | Hologic, Inc. |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.