FDA product code LMB: Device, Digital Image Storage, Radiological
LMB is the FDA product code for device, digital image storage, radiological. It is a Class I device, regulated under 21 CFR 892.2010 and reviewed by the Radiology panel. FDA has cleared 55 510(k) submissions under LMB, from 42 different applicants. The average 510(k) review took 120 days (median 87). FDA has posted 19 recalls for LMB devices.
Definition
Medical image storage hardware is a device that provides electronic maintenance and access functions for medical images.
Classification
| Field | Value |
|---|---|
| Device name | Device, Digital Image Storage, Radiological |
| Device class | Class I |
| Regulation | 21 CFR 892.2010 |
| Review panel | RA — Radiology |
| Medical specialty | Radiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every LMB clearance
Top LMB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Eastman Kodak Company | 4 | 1997-09-11 |
| Camtronics, Ltd. | 3 | 1995-12-11 |
| Eigen | 3 | 1994-04-07 |
| Sectra-Imtec AB | 2 | 1998-10-29 |
| O Tech, Inc. | 2 | 1997-12-02 |
37 more applicants have LMB clearances. See the full list in Caduvo.
Most recent LMB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K992131 | Samsung Sds Co., Ltd. | SAMSUNG RAYPAX LONG TERM ARCHIVE | 1999-09-13 | 82 |
| K984405 | Intracom Corp. | ECHOLIVE FAMILY, MODELS: ZL-1010,ZL-2000,ZL-2100,ZL-3000,ZL-4000 | 1999-02-08 | 61 |
| K983447 | Sectra-Imtec AB | WISE (II) IMAGE MANAGEMENT SYSTEM | 1998-10-29 | 29 |
| K980243 | Parameter Developments, Inc. | PARAMETER DEVELOPMENTS DICOM ARCHIVAL SERVER, (DAS)/DICOM INTRANET SERVICE (DIS) | 1998-04-03 | 70 |
| K973463 | O Tech, Inc. | OLICON IMAGING SYSTEMS, INC. ARCHIVE SYSTEMS, NT ARCHIVE, 02ARCHIVE, ARCHIVE | 1997-12-02 | 81 |
Recalls for LMB devices
19 product recalls in 19 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-04-04.
Frequently asked questions
What is FDA product code LMB?
LMB is the FDA product code for device, digital image storage, radiological. It is a Class I device, regulated under 21 CFR 892.2010 and reviewed by the Radiology panel.
What device class is LMB?
Class I, regulation 21 CFR 892.2010. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LMB?
Across 55 cleared submissions the average was 120 days from receipt to decision (median 87).
Which companies have the most LMB clearances?
Eastman Kodak Company (4); Camtronics, Ltd. (3); Eigen (3); Sectra-Imtec AB (2); O Tech, Inc. (2).
Have LMB devices been recalled?
Yes: 19 product recalls across 19 recall events; the most recent began 2016-04-04.
Next steps
- Run an FDA pathway report with predicate devices for product code LMB
- Run a recall and safety report across every LMB manufacturer
- Watch product code LMB for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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