(20 days)
The LASER IMAGER, DRYPRO MODEL 873 is intended to be used to acquire images from diagnostic equipment such as CT, MRI, DSA or FDA-approved Full Field Digital Mammography System and print the images on medical dry-film. The devices are intended to be used by trained medical personnel in a clinic or hospital environment.
The LASER IMAGER, DRYPRO MODEL 873 is a Medical Image Hardcopy Device to acquire images from diagnostic equipment such as CT, MRI, DSA or Full Field Digital Mammography System and print them on medical dry-film. The device consists of film supplying unit, film transferring unit, heat-developing unit, operating unit, power supplying unit and main control unit. This product employs semiconductor laser scanning and it complies with the Federal Performance Standard 21 CFR Part 1040.10.
The provided text is a 510(k) Summary for a medical image hardcopy device, the LASER IMAGER, DRYPRO MODEL 873. This document does not describe acceptance criteria, device performance, or any study involving AI or human readers.
The document focuses on:
- Company and Submitter Information: (Konica Minolta Medical & Graphic, Inc.)
- Device Identification: LASER IMAGER, DRYPRO MODEL 873 (Medical Image Hardcopy Device)
- Classification: Class II, 21 CFR 892.2040, Product Code 90 LMC
- Predicate Device: DRY LASER IMAGER, DRYPRO MODEL 793 (K042133)
- Device Description: Functions as a dry film printer for medical images from various diagnostic equipment (CT, MRI, DSA, Digital Mammography).
- Indications for Use: To acquire and print images from diagnostic equipment on medical dry-film, used by trained medical personnel in clinics or hospitals.
- Substantial Equivalence: Claims substantial equivalence to the predicate device due to similar intended use and technological characteristics.
- Compliance Standards: Mentions IEC60601-1, IEC60601-1-2, 21 CFR 1040.10, IEC60825-1 for safety and radiation.
- Conclusion: Reaffirms substantial equivalence to the predicate device.
- FDA Correspondence: An FDA letter confirming the 510(k) clearance based on substantial equivalence.
Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth, or AI-related metrics as it is not present in the provided text.
This 510(k) is for a hardware device (a printer), not an AI/ML software device. The evaluation process for such a device typically involves demonstrating adherence to safety standards, electromagnetic compatibility, and performance specifications like print quality and speed, usually by showing it is equivalent to a previously cleared device. It does not involve "acceptance criteria" related to diagnostic accuracy, sensitivity, or specificity in the way an AI diagnostic tool would.
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JUL - 1 2008
510(k) Summary
as required by 807.92
1. Company Identification
Konica Minolta Medical & Graphic, Inc. No. 1 Sakura-machi, Hino-shi, Tokyo 191-8511, Japan
2. Submitter's Name and Address
Koji Matsushima (Mr.) General Manager Regulation Management Division Quality Assurance Center 2970 Ishikawa-machi, Hachioji-shi, Tokyo 192-8505, Japan Telephone: 81-42-660-9607 Fax: 81-42-660-9588
3. Date of Submission
June 6, 2008
4. Device Trade Name
LASER IMAGER, DRYPRO MODEL 873
5. Common Name
Medical Image Hardcopy Device
6. Classification
Class II, 21 CFR 892. 2040, Medical image hardcopy device
7. Product Code
90 LMC
8. Predicate Device
DRY LASER IMAGER, DRYPRO MODEL 793, 510(k) Number: K042133
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9. Description of Device
The LASER IMAGER, DRYPRO MODEL 873 is a Medical Image Hardcopy Device to acquire images from diagnostic equipment such as CT, MRI, DSA or Full Field Digital Mammography System and print them on medical dry-film. The device consists of film supplying unit, film transferring unit, heat-developing unit, operating unit, power supplying unit and main control unit. This product employs semiconductor laser scanning and it complies with the Federal Performance Standard 21 CFR Part 1040.10.
10. Indications for Use
The LASER IMAGER, DRYPRO MODEL 873 is intended to be used to acquire images from diagnostic equipment such as CT, MRI, DSA or FDA-approved Full Field Digital Mammography System and print the images on medical dry-film. The devices are intended to be used by trained medical personnel in a clinic or hospital environment.
11. Substantial Equivalence to Predicate Device
The LASER IMAGER, DRYPRO MODEL 873 is substantially equivalent to our DRY LASER IMAGER, DRYPRO MODEL 793, 510(k) Number: K042133. Comparison of the principal characteristics is shown in the Section 2.
12. Compliance Standard
: IEC60601-1 Ed.2(1988)+ A1(1991)+A2(1995) Safety standard Electromagnetic Compatibility : IEC60601-1-2 Ed.2(2001)+A1(2004) Radiation safety : 21 CFR 1040.10, IEC60825-1(1993)+A1(1997)+A2:2001 DICOM
13. Conclusion
The LASER IMAGER, DRYPRO MODEL 873 has the same intended use and basically the same technological characteristic as the predicate device which is approved 510(k) number: K042133. This Special 510(k) has demonstrated substantial equivalence as the predicate device.
3-2.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL -1 2008 STORCH, AMINI, & MUNVES, P.C. % Mr. Koji Matsushima General Manager Konica Minolta Medical & Graphic, Inc. Regulatory Management Division, Quality Assurance Center 2970 Ishikawa-machi, Hachioji-shi 192-8505 Tokyo JAPAN
Re: K081637
Trade/Device Name: Laser Imager, Drypro Model 873 Regulation Number: 21 CFR 892.2040 Regulation Name: Medical image hardcopy device Regulatory Class: II Product Code: LMC Dated: June 6, 2008 Received: June 11, 2008
Dear Mr. Matsushima:
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 vour device is classified (see above) into either class II (Special Controls) or class III (P.MA), 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.
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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.
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 Center for Devices and Radiological Health's (CDRH's) 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Burgdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
inclosure
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Indications for Use
510(k) Number (if known)
Device Name
: LASER IMAGER, DRYPRO MODEL 873
Indications for Use:
The LASER IMAGER, DRYPRO MODEL 873 is intended to be used to acquire images from diagnostic equipment such as CT, MRI, DSA or FDA-approved Full Field Digital Mammography System and print the images on medical dry-film.
The devices are intended to be used by trained medical personnel in a clinic or hospital environment
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use · (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Aoyui Thi Whay
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(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
§ 892.2040 Medical image hardcopy device.
(a)
Identification. A medical image hardcopy device is a device that produces a visible printed record of a medical image and associated identification information. Examples include multiformat cameras and laser printers.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern). 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.