(51 days)
ANATOM 2000
Not Found
No
The summary describes standard CT image reconstruction and does not mention AI, ML, or related terms.
No.
The device is described as a diagnostic tool ("for diagnostic purposes, producing cross-sectional images") rather than one that provides treatment.
Yes
The "Intended Use / Indications for Use" states that the device is "intended for use as a Computed Tomography X-ray Sus on for diagnostic purposes".
No
The device is described as a "whole body CT scanning system" which inherently involves hardware components for generating and detecting X-rays, in addition to the software for image reconstruction. The description focuses on the function of a CT scanner, not solely on software processing of pre-existing data.
Based on the provided information, the Mayfield® ScanMate™ Mobile CT System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens taken from the human body (like blood, urine, tissue). The intended use and device description clearly state that this system is a whole body CT scanning system that produces images of the body through X-ray transmission data. This is an in vivo diagnostic method, meaning it examines the body directly, not a specimen taken from it.
The information provided focuses on imaging the body directly using X-rays, which is characteristic of an in vivo diagnostic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Mayfield® ScanMate™ Mobile CT System is a whole body CT scanning system. It is intended for use as a Computed Tomography X-ray Sus on for diagnostic purposes, producing cross-sectional images of the body through computer reconstruction of X-ray transmission data from the same axial plane taken at different angles.
The Mayfield® ScanMate™ Mobile CT System is intended for use as a Computed Tomography X-ray System for diagnostic purposes, producing cross-sectional images of the body through computer reconstruction of X-ray transmission data from the same axial plane taken at different angles.
Product codes
JAK
Device Description
Not Found
Mentions image processing
producing cross-sectional images of the body through computer reconstruction of X-ray transmission data from the same axial plane taken at different angles.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray transmission data
Anatomical Site
whole body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
ANATOM 2000
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
KoS3210
JAN G 2006 510(k) SUMMARY
Schaerer Mayfield USA, Inc.'s Mayfield® ScanMate™ Mobile CT System
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Schaerer Mayfield USA, Inc. 4900 Charlemar Drive Cincinnati, OH 45227
Phone: (513) 561-2241 Facsimile: (513) 561-0195
Contact Person: Teck W. Awa
Date Prepared: November 1, 2005
Name of Device and Name/Address of Sponsor
Mayfield® ScanMate™ Mobile CT System
Schaerer Mayfield USA, Inc. 4900 Charlemar Drive Cincinnati, OH 45227
Common or Usual Name
Computed Tomography X-ray System
Classification Name
Computed Tomography X-ray System
Predicate Device(s)
Analogic Corporation's ANATOM 2000
Intended Use / Indications for Use
The Mayfield® ScanMate™ Mobile CT System is a whole body CT scanning system. It is intended for use as a Computed Tomography X-ray Sus on for diagnostic purposes, producing cross-sectional images of the body through computer
1
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TM Mobile 0M 2000. The Mayfield® ScanMate™ Mobile CT System 1s as ses, indications for use, technological characteristics, and principles of n as its predicate device, ecomicrogical charactcrisites, and primetples of
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2
Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Schaerer Mayfield USA, Inc. % Mr. Jeffrey K. Shapiro Regulatory Counsel Hogan & Hartson L.L.P. 555 Thirteenth Street, NW WASHINGTON DC 20004
Re: K053210
2006
JAN 6
Trade/Device Name: Mayfield® ScanMate™ Mobile CT System Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: November 16, 2005 Received: November 16, 2005
Dear Mr. Shapiro:
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 (Premarket Approval), it may be subject to such 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 vour 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 (OS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your Section 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:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.
Sincerely yours,
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
4
· Indications for Use Statement
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: Mayfield® ScanMate™ Mobile CT System
Indications for Use:
The Mayfield® ScanMate™ Mobile CT System is intended for use as a Computed Tomography X-ray System for diagnostic purposes, producing cross-sectional images of the body through computer reconstruction of X-ray transmission data from the same axial plane taken at different angles.
Prescription Use __ X_ (Part 21 C.F.R. 801 Subpart D) AND/OR
Over-The-Counter Use_ (21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page _____ of
David A. Lyon
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number __
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