K Number

Device Name

MAMMOLOADER BY C.M.A. SRL

Manufacturer

C.M.A.

Date Cleared

1997-10-08

(49 days)

Product Code

IXW

Regulation Number

892.1900

Intended Use

The MAMMOLOADER is a device designed to unload and or load medical imaging films from the KODAK Mammography film cassettes (18x24 cm & 24x30 cm) and KODAK Video Film Holder (8x10 in), under roomlight conditions. Two versions are available; integrated with a medical imaging film processor so that when film cassettes are unloaded the film is sent directly into the film processor, or in a stand-alone version in which exposed films are unloaded from cassettes and placed into a receive magazine for processing at a later time.

Device Description

The MAMMOLOADER will be used to unload and or load medical imaging films from the KODAK Mammography film cassettes (18x24 cm & 24x30 cm) and KODAK Video Film Holder (8x10 in), under roomlight conditions. Two versions are available; integrated with a medical imaging film processor so that when film cassettes are unloaded the film is sent directly into the film processor, or in a stand-alone version in which exposed films are unloaded from cassettes and placed into a receive magazine for processing at a later time.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K905607

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the mechanical process of loading and unloading film and mentions integration with a film processor, but there is no mention of AI, ML, or any related concepts like image analysis or decision-making based on data patterns.

Therapeutic

No
The device is designed to load and unload medical imaging films, not to treat or diagnose patients. Its function is purely logistical in the context of imaging film handling.

Diagnostic

The MAMMOLOADER is designed to unload and load medical imaging films from cassettes, not to produce or interpret diagnostic information. Its function is purely mechanical in handling imaging films, either sending them directly to a processor or into a magazine for later processing. It does not perform any diagnostic function itself.

SaMD (Software as a Medical Device)

The device description clearly indicates a physical machine ("unload and or load medical imaging films from the KODAK Mammography film cassettes") with mechanical components ("integrated with a medical imaging film processor," "placed into a receive magazine"). This is not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, the MAMMOLOADER is not an In Vitro Diagnostic (IVD) device.

Here's why:

IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
MAMMOLOADER's Function: The MAMMOLOADER's intended use is to handle medical imaging films (specifically for mammography and video film). It unloads and loads these films from cassettes for processing.
No Specimen Analysis: The device does not interact with or analyze any biological specimens from a patient. Its function is purely related to the handling of imaging media.

Therefore, the MAMMOLOADER falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

90 IXW

Device Description

Two versions are available; integrated with a medical imaging film processor so that when film cassettes are unloaded the film is sent directly into the film processor, or in a stand-alone version in which exposed films are unloaded from cassettes and placed into a receive magazine for processing at a later time.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Typical users of this system are trained medical professionals, including but not limited to physicians, nurses and lab technicians.

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): 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.

KODAK X-OMAT Multiloader 300 (K905607)

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

Regulation Number and Section

§ 892.1900 Automatic radiographic film processor.

(a)
Identification. An automatic radiographic film processor is a device intended to be used to develop, fix, wash, and dry automatically and continuously film exposed for medical purposes.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Summary

973125

Department of Health and Human Services Center for Devices and Radiological Health Office of Device Evaluation Pre-Market Notification Section

OCT - 8 1997

Date: August 1, 1997

5 1 0(k) Summary of Safety and Effectiveness for the

MAMMOLOADER by C.M.A. srl, Via S. Andrea 23, 40064 Ozzano Emilia, Bologna Italy

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

Typical users of this system are trained medical professionals, including but not limited to physicians, nurses and lab technicians.

The undersigned certifies that the 510(k) Pre-Market Notification for the above referenced product contains adequate information and data to enable CDRH to determine substantial equivalence to the KODAK X-OMAT Multiloader 300 (K905607). This information and data is summarized as follows:

1. The MAMMOLOADER system is subject to and in compliance with the Federal Performance Standards, defined in 21 CFR, part 1000.
1. The MAMMOLOADER system has been and will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey.

(UL-122 photographic equipment, IEC 380, IEC 801-4, IEC 801-3, EN 55014 E POST, EEC 87/308 EMI regulations, and EN 60950 electrical safety.)

The MAMMOLOADER Operator Guide contains comprehensive and extensive information 3. on how to operate the system to ensure a safe and effective use.
1. The submission contains the results of an hazard analysis.

Onurcri

Mr. Massimo Azzaroni Director C.M.A. srl Via S. Andrea 23 40064 Ozzano Emilia Bologna Italy Tel: (39) 517-97306 Fax: (39) 517-96637

Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines representing its head and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 8 1997

Mr. Massimo Azzaroni Director C.M.A. srl Via S. Andrea 23 40064 Ozzano Emilia Bologna Italy

Re:

K973125 MAMMOLOADER by C.M.A. srl (Room light, cassette loader/ un-loader) Dated: August 1, 1997 Received: August 20, 1997 Regulatory class: II 21 CFR 892.1900/Procode: 90 IXW

Dear Mr. Azzaroni:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent for the indications for use stated in the enclosure) to 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). You may, therefore, 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 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or . other Federal laws or regulations.

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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours

W.Liau Yu

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Page 1 of -1

510(k) Number:

Device Name: MAMMOLOADER

Indications For Use:

Typical users of this system are trained medical professionals, including but not limited to physicians, nurses and lab technicians.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division
Division and Radio.	, ENT,
510(k) Num

Prescription Use	OR	Over-The-Counter Use
(Per 21 CFR 801.109)

(Optional Format 1-2-96)

and Radio...	Abdominal, ENT,
510(k) Number	K973125