(245 days)
Not Found
No
The description focuses on the hardware and image acquisition process (optical-based digital x-ray imager, CCD cameras, DICOM compatibility) and does not mention any AI/ML algorithms for image analysis, diagnosis, or other functions. The performance study is a simple image quality comparison to film, not an evaluation of AI/ML performance metrics.
No
The device is described as an X-ray scanner used for diagnostic imaging, not for treating diseases or conditions.
Yes
The device description states it "produces x-ray images that can be used for diagnostic purposes" and "the captured diagnostic image is stored in a database and is displayed on a high-resolution, medical-quality monitor, where the diagnosis can be performed." Its intended use is also in trauma wards "where multiple injuries can be medically diagnosed."
No
The device description clearly outlines hardware components like an x-ray scanner, fluorescent screen, CCD cameras, and a patient trolley, indicating it is a hardware-based medical device with associated software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The Lodox whole-body x-ray scanner is an imaging device that uses X-rays to create images of the internal structures of the body. It does not analyze biological specimens.
- Intended Use: The intended use is for medical diagnosis based on the visual interpretation of X-ray images, not on the analysis of in vitro samples.
- Device Description: The description clearly outlines an optical-based digital X-ray imager that converts X-ray energy to visible light for image capture. This is a physical imaging process, not an in vitro diagnostic process.
Therefore, based on the provided information, the Lodox whole-body x-ray scanner falls under the category of a radiological medical device rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Lodox is a digital x-ray imager intended as a replacement for x-ray film for general human radiography (excluding fluoroscopy, angiography, and mammography). It is specifically aimed at emergency room use.
Lodox allows radiographic exposures of the whole body including skull, spinal column, chest, abdomen, and extremities. Radiographic exposures may be taken of a patient lying on the patient trolley in any angle from the Anterior-Posterior view to the lateral view, or with the patient in the standing or prone positions.
The Lodox whole-body x-ray scanner is mainly intended for use in trauma wards where multiple injuries can be medically diagnosed in a very short time. It can also be used for normal x-ray examinations as is currently practised with general-purpose single-shot x-ray machines. A full image area is 1800 mm by 680 mm, and can be reduced to any size down to 100 mm by 100 mm anywhere within the image area.
Product codes (comma separated list FDA assigned to the subject device)
90MQB, 90JAK
Device Description
Lodox is a whole-body x-ray scanner that produces x-ray images that can be used for diagnostic purposes. It is an optical-based digital x-ray imager. It works by converting incident x-ray energy to visible light by use of a fluorescent screen optically coupled to a number of CCD cameras, which produce a digital image.
The captured diagnostic image is stored in a database and is displayed on a highresolution, medical-quality monitor, where the diagnosis can be performed.
The diagnostic image can be transmitted through a DICOM 3.0 compatible digital network for printing.
The imaging area can be set from 100 mm x 100 mm x 680 mm on a special purpose patient trolley.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Whole body including skull, spinal column, chest, abdomen, and extremities.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Emergency room
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Testing: tests were performed using line-pair resolution and high and low contrast targets. Resolution was found to substantially equivalent to the predicate.
Clinical Testing: In an image quality study, 39 human subjects were x-rayed both conventionally and with Lodox. A range of anatomy was covered representative of general radiography. The results were examined by a panel of two radiologists and found substantially equivalent to film.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K884671, K950883, 21CFR892.1840
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
AUG 0 6 2002
Image /page/0/Picture/1 description: The image shows the logo for Lodox, a company specializing in diamond sharp imaging. The logo features the word "LODOX" in large, bold letters, with the tagline "DIAMOND SHARP IMAGING" underneath. The company's website address, "WWW.LODOX.COM," is displayed below the tagline. The logo is simple and professional, conveying the company's focus on high-quality imaging.
KOI.3999
LODOX SYSTEMS (PTY) LTD P O Box 784055 Sandton South Africa 2146
Registration Number 2000/024615/07
+27 11 2693791 Tel: +27 11 2693792 Fax: E-mail: herman@lodox.com
510(K) SUMMARY
[As required by 21CFR807.92]
Date Prepared [21CFR807.92(a)(1)] 5.1
November, 2001
5.2 Submitter's Information [21CFR807.92(a)(1)]
| Company Name: | Centric Capital Ventures LLC (a
Delaware Limited Liability
Company) |
|-----------------|---------------------------------------------------------------------------|
| Establishment | |
| Registration | |
| Number: | 13-4104540 |
| Street Address: | 177 East 79th Street, Suite 4 |
| City: | New York |
| State/Province: | New York, 10021 |
| Country: | USA |
| Telephone: | 212-439-0746 |
| Facsimile: | 212-452-0756 |
| Contact Person: | Bradley Sacks |
| Contact Title: | Managing Partner |
| Contact email: | bradsacks@earthlink.net |
1
5.3 Trade Name, Common Name, Classification [21CFR807.92(a)(2)]
- Trade Name: Common Name: Classification Name: Device Class: Product Code:
Lodox Digital Radiography System Solid State X-ray Imager (SSXI) Class II 90MQB
Identification of Predicate Device(s) [21CFR807.92(a)(3)] 5.4 -
Equivalency is based on the Elscint EXCEL 2000 ELITE CT system (K884671) and the Siemens Polydoros 80 system (K950883) and bucky (x-ray film holder) using conventional radiographic film (21CFR892.1840).
Description of the Device [21CFR807.92(a)(4)] 5.5
Lodox is a whole-body x-ray scanner that produces x-ray images that can be used for diagnostic purposes. It is an optical-based digital x-ray imager. It works by converting incident x-ray energy to visible light by use of a fluorescent screen optically coupled to a number of CCD cameras, which produce a digital image.
The captured diagnostic image is stored in a database and is displayed on a highresolution, medical-quality monitor, where the diagnosis can be performed.
The diagnostic image can be transmitted through a DICOM 3.0 compatible digital network for printing.
The imaging area can be set from 100 mm x 100 mm x 680 mm on a special purpose patient trolley.
5.6 Intended Use [21CFR807.92(a)(5)]
Lodox is a digital x-ray imager intended as a replacement for x-ray film for general human radiography (excluding fluoroscopy, angiography, and mammography). It is specifically aimed at emergency room use.
Lodox allows radiographic exposures of the whole body including skull, spinal column, chest, abdomen, and extremities. Radiographic exposures may be taken of a patient lying on the patient trolley in any angle from the Anterior-Posterior view to the lateral view, or with the patient in the standing or prone positions.
2
Technological Characteristics [21CFR807.92(a)(6)] 5.7
| Feature | Lodox | Elscint
EXCEL
2000
ELITE CT
K884671 | Siemens
Polydoros
80
K950883 | Bucky with
Film /
Screen
892.1840 |
|--------------------------------------------------------|---------------------------|-------------------------------------------------|---------------------------------------|--------------------------------------------|
| 510(k)
Regulation | Pending | | | |
| Intended Use | General Human Radiography | | | |
| Fluorescent
screen to
convert x-rays
to light | Yes | Yes | No | Yes |
| Whole body
radiograph | Yes | Yes 1 | | No |
| Whole body
exposure 2 | 25 μGy | 80,5 μGy 1 | | - |
| Chest
exposure 3 | 0,21 mGy | - | | 2,57 mGy |
| CCD to
capture image | Yes | Yes | | No |
| CCD Pixel
Size | 26 x 26 μm | Not Available | | - |
| Half-Value
Layer | 4,35 mm | - | | 4,73 mm |
| Signal-to-
Noise Ratio | 2,57 | - | | 2,16 |
| Modulation
Transfer
Function 4 | 1,67 lp/mm 5 | - | | 2,34 lp/mm 4 |
| Detective
Quantum
Efficiency | TBD 6 | - | | TBD 6 |
| External
Connectivity | DICOM 3.0 | None | None | None |
| Image Storage | Hard Drive | Hard Drive | | X-ray film |
NOTE
-
- CT in scan mode.
- 2._ Measured on bed with no patient present.
-
- An average taken of 10 chest x-ray cases.
- 4_ Measured on bed, along its width, at 3% contrast.
5_ In normal resolution mode (5 x 5 binning) and perpendicular to scan direction. - 6_Work Group (WG33) in IEC/SC62B is currently developing a new IEC standard for measurement of the DQE of digital x-ray imaging detectors. This is due to be published within the first quarter of 2002. Lodox DQE performance will be determined according to this standard once it is published.
3
Non-clinical Testing [21CFR807.92 (b)(1)] 5.8
Lodox uses a fluorescent screen of the type used in film/screen radiography to convert xrays to light. A high-resolution, CCD-based, sensor captures this light.
To verify the spatial resolution and determine its equivalence to film, tests were performed using line-pair resolution and high and low contrast targets. Resolution was found to substantially equivalent to the predicate.
Clinical Testing [21CFR807.92 (b)(2)] 5.9
In an image quality study, 39 human subjects were x-rayed both conventionally and with Lodox. A range of anatomy was covered representative of general radiography. The results were examined by a panel of two radiologists and found substantially equivalent to film.
5.10 Conclusions [21CFR807.92 (b)(3)]
Images taken using the digital technology of Lodox were substantially equivalent to images taken on the Elscint EXCEL 2000 ELITE CT system based on the following:
-
- Whole-body radiographs could be taken on both systems.
Images taken using the digital technology of Lodox were substantially equivalent to standard film images based on the following:
- Whole-body radiographs could be taken on both systems.
-
- The results from studies showed that the digital images were comparable to film.
-
- Laboratory test results also supported the equivalence to standard film images shown in clinical studies. This clinical outcome supported the diagnostic imaging quality of the digital system as being equal to film/screen.
It was concluded that Lodox is equivalent to the Elscint EXCEL 2000 ELITE CT system (K884671) and the Siemens Polydoros 80 system (K950883) and bucky (x-ray film holder) using conventional radiographic film (21CFR892.1840) based upon the following criteria:
- Lodox has the same intended use as the predicate devices; and, ●
- Lodox has radiographic performance equivalent to the predicate devices. .
4
Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest. The profiles are all connected by a single line that runs from the top of the top profile to the bottom of the bottom profile. The logo is surrounded by the words "DEPARTMENT OF HUMAN SERVICES - USA" in a circular pattern.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Lodox Systems (Pty) LTD % Mr. Bradley Sacks Managing Partner Centric Capital Ventures, LLC 177 East 79th Street, Suite 4 NEW YORK NY 10021
Re: K013999
AUG 0 6 2002
Trade/Device Name: Lodox Whole Body X-ray Scanner Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomographic x-ray system Regulatory Class: II Product Code: 90 JAK Dated: May 10, 2002 Received: May 13, 2002
Dear Mr. Sacks:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
5
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on vour responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely vours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
4. SECTION D - STATEMENT OF INDICATIONS FOR USE
| Applicant | Lodox Systems (Pty) LTD |
|---|---|
| 510(k) Number (if known) | N/A K013999 |
| Device Name | Lodox X-ray Scanner |
Indications for use:
The Lodox whole-body x-ray scanner is mainly intended for use in trauma wards where multiple injuries can be medically diagnosed in a very short time. It can also be used for normal x-ray examinations as is currently practised with general-purpose single-shot x-ray machines. A full image area is 1800 mm by 680 mm, and can be reduced to any size down to 100 mm by 100 mm anywhere within the image area.
Prescription Use
Yorind A. higrom
(Division Sign-Off)
Division of Reproductive, Abdon and Radiological Device 510(k) Number