MAMMOLOADER BY C.M.A. SRL

K973125 · C.M.A. · IXW · Oct 8, 1997 · Radiology

Device Facts

• Record ID: K973125
• Device Name: MAMMOLOADER BY C.M.A. SRL
• Applicant: C.M.A.
• Product Code: IXW · Radiology
• Decision Date: Oct 8, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1900
• Device Class: Class 2

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

Device Story

MAMMOLOADER is a mechanical film handling system for medical imaging; operates under roomlight conditions to load/unload KODAK Mammography cassettes and Video Film Holders. Available in two configurations: integrated (direct feed to film processor) or stand-alone (unloads film into receive magazine for later processing). Operated by trained medical professionals (physicians, nurses, technicians) in clinical settings. Device automates film handling to facilitate processing workflow; ensures film integrity during transfer. No complex electronic processing or AI/ML components; device relies on mechanical transport mechanisms.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Mechanical film loader/unloader. Complies with UL-122, IEC 380, IEC 801-3/4, EN 55014, and EN 60950. Operates via electrical power. Available as integrated or stand-alone unit. No software algorithm or digital processing.

Indications for Use

Indicated for trained medical professionals (physicians, nurses, lab technicians) to load/unload medical imaging films from KODAK Mammography cassettes (18x24 cm, 24x30 cm) and KODAK Video Film Holders (8x10 in) under roomlight conditions.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• KODAK X-OMAT Multiloader 300 (K905607)

Submission Summary (Full Text)

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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.

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.

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.
- 2. 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.
- 4. 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: [phone] Fax: [phone]

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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510(k) Number:

Device Name: MAMMOLOADER

Indications For 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.

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 |